Total 16 job vacancies by Biosensors Interventional Technologies Pte. Ltd.

Summary

Responsible for Engineering work activities on handling daily issues in the production line, manufacturing documentation, new process transfer into production, and process improvement.

Roles and Responsibilities

• In-charge of engineering support for production and ensuring that it meets the daily target on quality, output, yield, and delivery.
• Ensure compliance with QMS, cGMP, and regulatory requirements in manufacturing activities.
• Ensure that goods and services are produced at the production at right efficiency, cost, and level of quality.
• Perform process, software, and equipment validation. (IQ, OQ, PQ, etc.)
• Establish, update and maintain process documentation. (WI, form, drawing, BOM, Risk Assessment, Risk Management, etc.).
• Maintain the label printing process. (Label printing artwork)
• Conduct manufacturing process training for production staff.
• Lead a team to investigate and analyse the root cause of process issues and non-conformances. Implement and evaluate the effectiveness of corrective and preventive actions.
• Work on continuous improvement activities in the manufacturing line and follow up with the implementation.
• Support for the transfer of new processes and products into the production phase.
• Build a teamwork culture.
• Other related duties as assigned.

Requirements

• Minimum a Bachelor's Degree in Mechanical/Industrial/ Manufacturing Engineering or equivalent.
• Minimum 2 years of work experience in medical device manufacturing will be advantageous.
• Fresh graduate is acceptable.
• Knowledge and competency in Risk Management, EN ISO 14971
• Basic knowledge of the engineering methodology such as LEAN, 5S, and Six Sigma.
• Basic knowledge of project management, process validation strategy, and quality tools.
• Ability to manage the project and complete it on time.
• Good communication, and teamwork skills.
• Good interpersonal skills.

Summary

The Customer Service Manager will be responsible to lead the Customer Service Team in the Order to Cash process for Asia-Pacific Region and ensuring the team are operating in accordance to corporate policies, International regulations and compliance.

Responsibilities

• Provide leadership to Customer Service team and to meet corporate and departmental strategic objectives
• Establish goals and monitor performance achievement through performance reviews
• Manage and distribute team workload and provide inputs for succession planning
• Mentor, coach and empower team members and promote teamwork
• Support team to remove barriers, resolve conflicts and drive for accountability
• Communicate, Review and Monitor team members performance to established metrics, policies, procedures and goals to meet department and company strategies
• Ensure a safe, compliant and ethical working environment for the team
• Ensure team members are well-trained according to standard operating procedures, department compliance and work requirements
• Identify learning opportunities and provide training
• Collaborate with other departments and peers to develop regional solutions
• Identify, participate and drive system and process improvements
• Maintain knowledge of and apply company and local safety, labor, and ethics policies
• Communicate requirements to applicable team members and external stakeholders
• Oversee execution of mandatory training for direct reports
• Support all audits
• Responsible to implement the Standard Operating Procedure for the Order to Cash process in APAC
• Awareness and situational involvement in order management issues; To be the point of contact for Order management issues and escalated matters
• Ensure compliance to SOP by establishing guidelines and frameworks for the team
• Support Customer Service and Sales Team on the monthly/quarterly billing timeframe

Requirement

• Relevant Bachelor’s degree or equivalent with 6-10 years of similar experiences
• At least 2-3 years of supervisory experience and track record to manage a team of 5
• Experienced in SAP SD module with Knowledge on Order Management and Consignment Business (Knowledge on Letter of Credit will be added advantange)
• High level of integrity and able to work under stress and deliver within work schedules
• Good Interpersonal skills to build rapport across different functions and support to the team
• Meticulous to details and well organized routines
• Self motivated/driven individual who takes initiatives to engage and solve and close the gaps/issues
• Good command of English and skilled at delivering the message to audience
• Problem identification and solutioning and support for brainstorming and decision making

Summary

The Sales Executive is responsible for the sales of Biosensors and 3rd party products in the territory. He/she is directly responsible for achieving the sales revenue, independently plan and organize weekly/daily schedule to call on existing accounts, obtain orders and establish new accounts. Covering CVL case as needed and be on team monthly roster for oncall support. Actively involved in consignment stock management in his/her responsible hospitals to ensure a healthy inventory with minimal stock write off. Gather and monitor market and competitor’s information for reporting to the management. He/she should establish strong relationships with Physicians, Nurses, Technicians, Purchasing Officers to pursue key accounts and conduct business discussion. He/she should also ensure businesses are conducted in a fair, ethical manner with compliance to company policies.

Responsibilities

• Achievement of sales revenue of a given territory
• Planning and organizing weekly / daily schedule to call on existing accounts, obtains orders and establishes new or potential accounts
• Covering CVL case as needed of given territory and be on team monthly roster for oncall support for country wide
• Performs product presentations / in services, product evaluations to existing and new or potential accounts
• Submits orders promptly with accurate billing information and in accordance to price guide
• Prepares quotation / tender documents
• Maintains a healthy inventory by establishing correct consignment stock level, perform stock rotation to minimize stock write off and removal of expired stock promptly from the shelf
• Ensures all sales activities comply with legal and ethical standards, and that documented processes, procedures and internal quality management system are followed and adhered to
• Keeps management informed by submitting activity and results reports, such as daily call reports, weekly work plans, and monthly and annual territory analyses
• Presents sales reviews including market share analysis, sales forecast and territory management
• Develops strong KOL relationship and identification of young upcoming doctors for business continuity
• Monitors competition by gathering current marketplace information on pricing, products, new products, promotion, etc. Provide such market information promptly to the marketing team
• Recommends changes in products, service, and policy by evaluating results and competitive developments
• Resolves customer complaints by investigating problems; developing solutions; making recommendations to management
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks
• Provides historical records by maintaining records on area and customer sales
• Assist the marketing team in the organization of sales and marketing activities (e.g. workshop, exhibition booth)
• Assist the R&D team and clinical team in the development of new products with KOL, product/clinical trials and registries
• Assists in the development of less experienced sales reps to extend skills and expertise of individual
• Contributes to team effort by accomplishing related results as needed

Requirement

• Degree in Biological Sciences, Business Administration, Nursing or related discipline
• 3 - 5 years of successful direct sales experience in medical device or pharmaceutical company
• Prior experience in Cardiac Technology, particularly in IVUS or Cathlab, would be advantageous
• Demonstrates ability to absorb technical knowledge quickly and disseminate appropriately to healthcare professionals
• Good communication and presentation skills
• Independent, high energy level, ambitious, with a strong desire to succeed
• Possess own car and have valid licence

Responsibilities

• Responsible for managing and administration of Singapore end to end payroll cycle for 400+ paxes including blue collar workers, and to ensure accuracy and compliance with all Employment Act and regulatory
• Responsible for working together with outsourced payroll vendors to facilitate and managing APAC countries payroll cycle
• Responsible for timely tax filing (including but not limited to IR21 and IR8A), CPF submission, all government claims and statutory pay requirements.
• Administration of ePayroll systems and manage all payroll outsourced vendors.
• Validate all payroll supporting data and documents to be accurate and truthful and ensure all payments and deductions are correctly updated into the payroll system.
• Ensure timely data update in payroll systems and related HRIS systems for payroll processing purpose.
• Maintain and archive supporting payroll documents and authorizations for internal and external audits.
• Maintain all payroll related reports for Finance/Payroll/Headcount report/Levy/MOM Surveys and ensure all report data are trackable in payroll system and authorised supporting documents.
• System administration of ePayroll system include Timesoft, BIPO Payroll system.
• Ensure employee benefits including claims and reimbursements as per rules and regulations.
• Other ad-hoc duties as assigned.

Requirements

• Diploma/Degree in Human Resources, Business Administration, Accounting, or related discipline.
• With at least 3 years of hands-on payroll full cycle experience. Preferably experience with TimeSoft system, BIPO payroll system.
• Must have experience in handling blue collar workers’ payroll related
• Working knowledge of Employment Act for manufacturing or similar industries.
• Proficient in MS Word, Excel (Pivot, Vlookup, etc)
• Ability to work independently and as a team.
• Ability to multiple task and work under tight deadlines.
• Good interpersonal and analytical skills.
• Meticulous, diligent, proactive, and analytical.

Roles and Responsibilities

• To lead or full medical device new product development project lifecycles from concept stage through design, developing, component procurement, assembly , test, verification and validation and to manufacturing transfer and product launch.
• To lead or support, coordinate, and execute in continuous improvements projects, cost-down projects, and sustaining activities to meet the clinical and business needs.
• To lead or actively participate in and act as the technical lead for cross-functional teams from sales & marketing, regulatory, quality, and manufacturing teams to ensure cost-effective and sustainable product standard
• Provide guidance to junior engineers and technicians, and other stake holders
• To lead or execute in all required technical documentation works.
• To participate and contribute to cross-functional team activities

Requirements

• Minimum Degree in Mechanical, Materials, Bio-Engineering or relevant.
• 2-6 years’ relevant working experience in a medical device industry preferred.
• Good product design and process development knowledge and experience with strong analytical skills.
• Experience with medical device design, manufacturing process in a regulated industry environment will be beneficial.
• Strong verbal and written communication skill to communicate with internal and external stakeholders in China/Singapore/Europe
• Proven strong team player with good interpersonal and communication skills.
• Good technical documentation skills relevant to professional reports

Responsibilities

• Manage end-to-end Supply Chain planning from purchase of raw materials to manufacturing of Sub-assembly and finished goods; ensuring that supply meets demand in timely manner with optimum inventory holding goal.
• Handle order enquiry and fulfilment for inter-company stakeholder to support their region / entities Sales.day issues from Supply Chain - Planning.
• Responsible for operation management and control of entire order process from point of order (OEM order from customer; demand and release plan) to execution completion (ready for sales) within an acceptable time frame
• Manage inventory level to ensure the target level is optimal and aligned to supply chain direction.
• Check material availability and liaise with various departments on any supply constraint / shortages.
• Generate and analyse MRP report.
• Generate and monitor purchase order, ensuring purchases are promptly placed, schedule in / push out accordingly base on requirement and follow through till payment is completed.
• Co-ordinate and handle logistics flow and invoice verification.
• Responsible and monitor inventory holding level (quantity, value) and minimize any scrap or obsolescence.
• Follow up and monitor on any document change request (TDN, BOM) that would affect production order if left unattended to.
• Collaborate and resolve exceptions caused by forecast errors on order timing / quantities.
• Identify current and potential product shortages, develop and execute recovery, advise stakeholder of status and recovery plan.
• Generate and publish weekly / monthly report (E.g. released plan, cycle time, demand attainment, inventory holding etc.)
• Regularly liaise and handle query and order fulfilment / return of internal customer focus (E.g. cross entities / business unit) ensuring the stock availability to meet global requirement / demand.
• Identify opportunities of inventory (Shelf life or quantity) rebalancing within entity warehouse.
• Undertake other tasks or team participation as required by management.
• Being a subject matter expert in the department and able to provide guidance and mentor planner within the department.

Requirements

• At least 3 years of experience in Production Planning, Scheduling and Manufacturing
• Minimum 3 years of relevant experience in high volume and dynamic Manufacturing Environment
• Proven ability to manage multiple projects and work under tight deadlines.
• Familiar with MRP / ERP environment.
• Decision making and judgment.
• Possess initiative and good interpersonal skills.
• Microsoft Excel application & tools for complex data analysis.
• Self-motivated and hardworking.
• Good team player.

Roles and Responsibilities

• To lead or full medical device new product development project lifecycles from concept stage through design, developing, component procurement, assembly , test, verification and validation and to manufacturing transfer and product launch.
• To lead or support, coordinate, and execute in continuous improvements projects, cost-down projects, and sustaining activities to meet the clinical and business needs.
• To lead or actively participate in and act as the technical lead for cross-functional teams from sales & marketing, regulatory, quality, and manufacturing teams to ensure cost-effective and sustainable product standard
• Provide guidance to junior engineers and technicians, and other stake holders
• To lead or execute in all required technical documentation works.
• To participate and contribute to cross-functional team activities

Requirements

• Minimum Degree in Mechanical, Materials, Bio-Engineering or relevant.
• 2-6 years’ relevant working experience in a medical device industry preferred.
• Good product design and process development knowledge and experience with strong analytical skills.
• Experience with medical device design, manufacturing process in a regulated industry environment will be beneficial.
• Strong verbal and written communication skill to communicate with internal and external stakeholders in China/Singapore/Europe
• Proven strong team player with good interpersonal and communication skills.
• Good technical documentation skills relevant to professional reports

The System Analyst is a member of the Global Center of Excellence. The candidate will act as the gatekeeper of Biosensors' blueprint document (BPB) and is the key to ensure its integrity and completeness. The candidate will routinely review the BPB and align it with the growth of the company. Candidate will also provide guidance and direction to the roll-out consultant and ensure that the new implementation is in-line with the agreed business processes.

Responsibilities

• Manage and govern Biosensors blueprint Document. Regularly review and update the document to keep it relevant and in-line with Biosensors business growth.
• Lead and provide guidance to the functional and technical teams to ensure the solution designed does not deviate from the BPB.
• Provide 1st and 2nd level support to the business and ensure issues are properly closed and resolved.
• Organise and lead the functional and regression testing exercises.
• Review deliverables submitted by the roll-out team and ensure the document complies with Biosensors policies and procedures.
• Ensure the integrity and relevancy of the business process blueprint.
• Successful roll-out of the responsible modules in any implementation and ensure the project is properly documented.
• Ensure support tickets are properly resolved and closed in a timely manner per the service level agreement.
• Maintain high level of user experience with IT solutions and services.
• Maintain high system availability of IT solutions and services.
• Manage compliance with existing rules / regulations
• Provide and deliver ideas for improvements, in own areas and others
• Lead and be involved in improvement/implementation projects

Skills

• Minimal 5 years SAP FICO experience with at least leading 3 full cycle module roll-outs.
• Extensive experience with business processes and familiar with ASAP implementation activities.
• Experience with Process Mapping and Documentation.
• Ability to create and write formal proposals, recommendations and business cases.
• Experience in dealing with all levels within the business from end users to the management board in a complex stakeholder environment and capable of presenting ideas, recommendations, projects and business cases in a non-technical manner.
• Ability to communicate and interact effectively with people (internally and externally) at all levels.
• Ability to coach and mentor others by sharing knowledge and experiences.
• Proven people management and development skills.
• Ability to analyze problems from both a business and technical viewpoint.
• Effective problem solver with ability to examine and re-engineer processes, procedures and practices.
• Ability to think laterally to conceptualize and visualize solutions.
• Ability to plan and be systematic.
• Ability to work effectively individually as well as within a team.
• Ability to prioritize and meet deadlines.
• Excellent written and oral communication skills.
• Possess recognised degree in information technology or computer sciences or equivalent substantial information services experience in a commercial environment.

Summary

• Provide the day-to-day administrative support for order processing, billing and shipment for Customer Service division.
• Manage the designated customer accounts in achieving customer satisfaction and be in compliance to company’s quality standard.

Responsibilities

• Supporting, assigned tasks or back up for Customer Service peers and ensuring that the services provided to customers are of maximum satisfaction
• Preparing reports and feedback to mangers on a monthly basis or as required
• Process and follow-up the day-to-day administrative support on order processing, billing for Customers’ Orders, Samples, Consignment and all related orders with External Customers, Service Providers and Internal functions
• Execute timely shipping arrangements with Customers, forwarders or respective service providers & related functions
• Generate billing Invoices and shipping documentations (E.g. Packing Lists, Commercial Invoices and others depending on customs and customer requirements)
• Track inventory against customer’s orders and work with the respective functions to have inventory released or stock rotation (RGA / Consignment return) when necessary
• Attend to customers’ Inquiries and requests
• Coordinate and follow-up on new customer’s requirement or assigned Projects
• Process Product Complaints for Product Replacement or Credit transaction
• Process CN (Credit Notes) and DN (Debit Notes) requisition for required transactions
• Process and follow-up on RGA and Consignment return request.
• Files all correspondence to be in compliance to SOP and WI
• Responsible to manage all aspects of the assigned accounts for APAC region and intercompany

Requirement

• Minimum NITEC Holders
• 3-5 years of experience in Orders Processing & Fulfilment, Shipping and L/C Documentation
• 3-5 years of experience in a customer service role
• Passionate about customer service and Excellent communication skill
• High level of integrity and able to work under stress with on-time deliverables
• Good communication and interpersonal skills
• Team player and proactive in team discussion
• Problem solving kills; to use rigorous logic and methods to solve problems with effective solutions
• Self starter and independent
• Meticulous and an initiative individual

Position Summary

Responsible for the execution of the overall calibration & maintenance system/services for the equipment and instrument in manufacturing, QA and R&D.

Position Responsibilities

• Provide solution and technical support on equipment related issue.
• Perform performance assurance inspection, scheduled maintenance, electrical safety inspection, and operation verification procedure on equipment.
• Install, set-up, maintain, repair and calibrate equipment.
• Ensure compliance to cGMP, environmental health, safety guidelines and any other related regulations that could apply.
• Inform team leader of the status of repairs, scheduled inspections, unusual equipment situations, and any equipment related concerns.
• Work with, direct, and document the activities of subcontractors, vendors, and outside service technicians to ensure proper service delivery.
• Ensure the accuracy and integrity of the equipment database to include the inventory, performance assurance schedules and service history.
• Ensure all service and documentation (operation manual and maintenance procedure) is complete, up to date, and accurate.
• Verify the completion of technical and security analysis for new equipment.
• Maintain the accuracy and integrity of the equipment database to include inventory, performance assurance schedule, nomenclature, and service history.
• Perform periodic inspection of current inventory status of maintenance part and purchase the part as needed.
• Make recommendation regarding inventory and the spare critical equipment.
• Other duties as assigned.

Experiences, Knowledge, Skills and Abilities

• Minimum NITEC or diploma technical qualification or equivalent.
• Minimum 2 years of work experience in equipment maintenance will be advantageous.
• Good troubleshooting skills on equipment, and able to work independently.
• Good knowledge in operating, controlling, and troubleshooting mechanical and electrical device.
• Ability to read, analyse and interpret technical procedures, and governmental regulations.
• Willing to work rotating shifts according to planned duty roster and to be standby (on-call).
• Good communication, and teamwork skills.
• Good interpersonal skills.

Summary

In this role, you will be reporting directly to and work closely with the Associate Marketing Director to develop and implement marketing strategies, programs and plans to meet and exceed financial objectives. He/she will work with the Marketing / Product Specialist in each country for overall product marketing of Biosensors portfolio products within the Asia Pacific region, ensuring key marketing support is provided at country level.

Responsibilities

• Deliver overall Marketing product positioning, messaging, clinical data, at country and hospital level to drive sales of the Biosensors stent and dilatation catheter portfolio and 3rd party products.
• Leading and managing the Product Life Cycle that includes the business case development, launch and marketing plans, and programs aligned with the countries strategies.
• Strengthen the implementation and executions of marketing events and workshops through close team work with regional country managers, sales team as well as to train internal customers on product features and benefits and to conduct post market follow up and analysis.
• Conceptualize and prepare marketing materials and training materials; conduct training to the sales team and distributors to equip them with knowledge of selling features and functionality of the products.
• Perform analysis of market data research to understand market trends, pricing, market dynamics and positioning.
• Work with Country manager to manage major hospital tender / National tenders, implementation and management of data usage analysis and strategy plan to win major hospital tender / National tenders continuously.
• Understand the clinical environment to be able to deliver product messaging in line with the overall strategic direction.
• Work closely with Clinical team to support regional/local registries.
• Spend significant time in the field working with Biosensors country sales teams and understanding regions, hospitals and market differences in each country and provide clear support to achieve revenue goals.
• Develop effective sales tools to support the sales team and also to coach local sales teams in aligning sales messaging and executing tactical sales activities.
• Build and maintain working relationships with key opinion leaders to facilitate Biosensors market entry, early DOH approval and reimbursement approval in regulated countries.
• Work closely with Regulatory Affair to lobby against local government to speed new products to market and gain upside for future sales.
• Ensure all marketing expenses are used appropriately with best leverage and not exceeding the given budget.

Requirement

• Degree in Science, Biotechnology or any other related disciplines
• Minimum of 5 years sales and marketing experience in Interventional cardiology or related field
• Proven ability to deliver key messaging on a product and clinical basis to internal and external stakeholders
• Excellent interpersonal and communication/presentation skills
• Understanding of clinical data and its interpretation to present to internal and external stakeholders
• Adaptable and able to work with colleagues and customers from Southeast Asia region and culture sensitive
• Strong analytic marketing knowledge and sales support
• Highly organized and result oriented, effectively utilizes time and stay on top of shifting priorities
• Effective Project Manager, able to keep projects on schedule while performing additional unrelated tasks
• Excellent knowledge of MS Office

Job Summary

To be responsible for engineering activities in product improvement/engineering projects; performs engineering analysis, equipment and process set up, carry out risk assessments and validations as well as production implementation for completed projects.

Job Responsibilities

• Participate in product improvement/engineering projects, and responsible for engineering activities.
• Take the lead in problem solving and action planning in project management.
• Perform risk analysis (FMEA) to define process flow and control plan.
• Perform equipment qualification and process validation for product improvement/engineering projects.
• Provide technical advice and guidance to junior engineers and other departments.
• ·Ensure projects are implemented in line with the schedule and budget.
• Optimize new/improved process parameters to further improve product quality and the overall equipment effectiveness.
• Explore new process to improve product quality or productivity.
• Be responsible for the successful transfer of new/improved process/methodologies into the production with good process margins and inline controls.
• Involved in hands-on execution of manufacturing operations.
• Provide operational training for operators or related personnel.
• Manage administrative duties as well as ad-hoc projects assigned by immediate superior.

Job Requirements

• Minimum a Bachelor Degree in Mechanical/Industrial/Manufacturing/ Biomedical Engineering related disciplines or equivalent.
• Good mechanical or material aptitude and knowledge.
• Good experience of manufacturing process and cGMP manufacturing.
• Experience of operational management and lean manufacturing.
• Clean room/environment control experience.
• At least 2 years of working experience in the related field.
• Excellent English-speaking & writing skills
• Multi-lingual: Chinese (Mandarin) to liaise with Mandarin speaking counterparts, other languages are an asset
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to write professional reports, business correspondence, and procedure manuals.

Job Summary

This potential candidate will support in routine testing by performing in a day-to-day operation in the chemistry and physical lab routine operation for all finished product lot release samples. He / she must possess basic analytical skills and judgement to interpret test data by analysing basic scientific assessment. Additionally, the candidate will have to ensure that there are adequate suppliers and consumables in the laboratory to support the lot release testing activities. The candidate should also be able to assist in laboratory investigation, documentation and audit. He / she needs to participate in the management of calibration, maintenance and qualification of laboratory equipment and the cleanliness of the laboratory within the testing stations.

Job Responsibilities

• To support the day-to-day chemistry and physical laboratory activities perform testing on finished products and / or other non-routine testing such as stability studies, validation studies, developmental prototype and clinical products.
• Maintain laboratory equipment to ensure they are performing for its intended usage.
• To be able to assist and support in basic troubleshooting for equipment and process issues.
• Support laboratory investigation on equipment failure documentation of non-compliance or out-of-spec situations.
• Ensure tests assigned are performed in a timely manner in compliance to SOP, cGMP and GLP with a precaution of laboratory safety.
• Assist in the laboratory administrative work not limited to glassware washing, printing of test results and data entry of test results into given tools and system.
• Liaise and coordinate with external vendors in carrying out calibration / maintenance of lab equipment when necessary.
• Able to work closely with supervisor and team members on the requirements of new projects and improvement to achieve annual key performance.
• Perform second person verification of other technician work.
• Perform and maintain an acceptable level of 5S housekeeping in accordance to the Good Laboratory Practice.
• To be able to support in revising and amending standard operating procedures to reflect current standards and practice in place.
• Other adhoc laboratory matters and duties assigned by direct supervisor.

Job Requirements

• ·Diploma in Science discipline (e.g. Chemistry, Pharmaceuticals, Chemical Process)
• Preferable with at least 1-2 years relevance experience in a laboratory environment, fresh Diploma or Higher NITEC graduates are welcomed to apply.
• Ability to speak English and Mandarin
• Microsoft Office Applications such as Excel, Word and PowerPoint
• Possess ability to operate LC, GC, and UV-Vis Spectrophotometer independently.
• Basic knowledge in GLP and analytical test methods.
• Good Interpersonal and communication skill and possess positive attribute
• Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC), ISO 9001, EN 46001 and ISO 13485
• Basic knowledge of chemistry and related fields
• Good analytical skills.

Job Summary

To lead and supervise Incoming Store, Production Kitting and Outgoing Store team in ensuring:

• On time completion of routine activities
• Store processes are in compliance to cGMP, Quality Management Systems and regulatory requirement.

Job Responsibilities

• Management and monitoring store activities to achieve on time completion and efficiency.
• Responsible and accountable for achieving both quality and productivity objectives by streamlining the process and drive continuous improvement.
• Demonstrate discipline and inculcate teamwork and support within store sections.
• Maintain a high standard of 5S housekeeping practice and habits.
• Identify and eliminate any possible risks to ensure a safe working environment.
• Maintain inventory accuracy, control and adjustment.
• Review and plan with the supervisor on the training and development needs of all store personnel
• Conduct training or refreshment training on new / revise policies or procedure to store assistants (E.g work instruction, ERP system), ensuring policies and procedure are understood and comply with.
• Responsible for the upkeep and maintenance of all material handling equipment assets.
• Coordinate and liaise with internal and external stakeholders to ensure consistent work flow.
• Generate and distribute monthly reports (E.g GR, Issuance, Inventory, RGA, RTV, Scrap, Sample, On-hold etcs…)
• Generate, arrange, reconciliation and do adjustment for weekly cycle count and year end stock count.
• Ensure proper storage and handling of controlled materials.
• Oversee daily store administration (e.g. Documentation, conducting random checks and audits on housekeeping control, temperature control, rework procedure, RGA, Incoming and outgoing shipment documentation, inventory maintenance etc.
• Assist in internal and external audits.
• Management of Known Consignor Regime documents and inspections.
• Other ad-hoc duties as assigned by manager.
• Subject Matter Expert for warehousing.

Job Requirements

• Minimum 5 years of store / warehouse experience, with at least 2 years experience in a supervisory position.
• Knowledge in store / warehouse activity including book keeping and ERP systems.
• Experience in cGMP, ISO 13485 is an added advantage.
• Ability to converse to teammates and counterparts in English and Mandarin
• High level of integrity and able to work under stress and deliver work schedules
• Good problem solving abilities, communication and interpersonal skills to build cross function and support
• Driven and independent
• Able to understand and compile data and use it for analytical problem solving.

Job Summary

• Provide Quality Engineering support to R&D teams for new product development and product enhancement via Design Control process.
• Provide support to Clinical team for pre-market device deficiencies and Complaint Handling Unit for post-market complaints investigation.
• Coordinator of Risk Management process within the organization
• Responsible for carrying out quality programs that contribute to improve both product and process quality and reliability, and to minimize risk exposure through control systems, procedures, methods and practices designed to carry out these objectives consistently.
• Participate in the scheduling of engineering changes and operation flow as well as company-wide improvement programs and assigned quality projects.
• Support the global PMS program, and responsible for timely complaint investigation for on-time vigilance reporting and complaint cases closure.

Job Responsibilities

• Identify quality requirements and support design control process and design history files.
• Provide QA related support for new product development and product enhancement.
• Generate or review validation/verification documents, provide support to Quality investigation related to Validation/Verification reject investigation.
• Generate or Update Quality related documents such as Quality Plan, Quality Inspection documents and Lot release Documents during the development phase.
• Coordinate the update of incoming material specs and FAI activities with the Supplier Management Group during the development phase.
• Lead and perform Product Risk Management for current, new/enhanced products.
• Maintain Risk Management Files and Risk Management Plans in accordance to EN ISO 14971.
• Carry out DHR review, returned device decontamination and returned device investigation.
• Responsible for returning of 3rd party complaint products to manufacturers.
• Involve in internal audits, external audits and Quality Assurance related projects when required.

Job Requirements

• A Bachelor's degree in engineering
• At least 1-2 years of medical device experience
• Ability to communicate in English
• Experience in Problem Solving
• Cleanroom/environmental control experience is preferable
• Excellent interpersonal and communication skill and possess positive attributes
• High level of integrity and able to work under stress and deliver work as per scheduled
• Good communication and interpersonal skills to build cross function and support
• Self-starter and independent
• Familiar with ISO 13485, ISO 14971, ISO 25539 and ISO 10555 requirements
• Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC) and MDR (2017/745)
• Knowledge of FMEA, Design Control, Statistical Process Control (SPC) and Problem Solving Tools is preferable
• Able to recommend critical decisions with calculated and justifiable risk through analytical thinking