JOB SUMMARY
Work towards excellent customer satisfaction with quality with products manufactured for the assigned Life Science customer(s), working with the cross-functional team under respective TCS (Total Customer Satisfaction).
JOB RESPONSIBILITIES
• Contact point, for assigned customer account, to liaise with customer Quality representatives on quality matters.
Investigate customer complaints on quality, including Corrective Action request, Failure Analysis report, with internal cross-functional team for comprehensive root cause failure analysis, corrective action plan and ensure closure with effective implementation of corrective actions and preventive actions.
• Monitor product quality performance and present reports; chair internal quality improvement meetings with
Manufacturing and Engineering to reduce the customer reject;
• Under the guidance of Quality Lead, to participate in quality Improvement Initiatives to drive customer
satisfaction with quality score-card.
• Review material non-conformance complaints by Manufacturing against specification, and for confirmed non-
conforming parts, to seek failure analysis, and corrective action from supplier.
• Perform key supplier audit and assessment of supplier quality performance.
• Develop, implement, and maintain quality inspection instruction, checklist, control plan for new product
introduced.
• Perform quality audit on manufacturing line for compliance to applicable standards and procedures.
• Be the advocate and influencer for excellent Quality practices.
Authority:
• Activate purge and recall non-conforming finished goods, if necessary.
• Activate stop shipment in the event of product non conformity until issue is resolved for resumption
• Request Investigation and/or Corrective Action from internal stakeholders for non-conformance
• Request Investigation and/or Corrective Action from suppliers for non-conformance
EDUCATION and EXPERIENCE
• Local fresh Graduates with Growth Mindset are welcome to apply.
• On-the-Job training, self-learning through Job Shadowing, formal classes, certifications are available to
those who apply themselves to the role.
• For those with working experience, the relevant areas are as follows:
• Quality Assurance function:
• Manufacturing (especially contract-based)
• Life Science Instruments
• Electronics/ Mechanical/ Bio-Medical/ Mechatronics
• Quality Standards: ISO13485
• Regulatory: FDA 21 CFR p820
JOB-RELATED SKILLS & PRE-REQUISITES
• Relevant job-related skills are as follows:
• Corrective and Preventive Action methods for example 8-Discipline
• Risk Management tools, for example Failure Mode and Effect Analysis and Control Plan
• Validation methods including Installation Qualification, Operational Qualification and Performance
Qualification
• Statistical techniques including Cpk analysis, Control Plan, Measurement System Analysis (Gage R&R)
• Metrology/ Lab equipment including Coordinate Measurement Machine, Caliper, Vision Measurement
• Communication skills including negotiation and influencing customers, suppliers and internal
stakeholders.
• Local fresh Graduates are welcome to demonstrate any of the above skills for example through school
projects, voluntary services, and part-time work.
