Our client is a well-known manufacturer of Life Sciences equipment
• Manage suppliers to ensure all part quality requirements are met
• Lead supplier qualification activities for new suppliers with Procurement Engineering & Global Supply Chain
• Conduct on-site audits for qualification of new and existing suppliers to ensure supplier’s QMS is meeting ISO standards and where applicable, FDA QSR (GMP)
• Carry out ongoing monitoring of (critical) supplier performance, including periodic audits and periodic quality reports/scorecards.
• Continual improvement actions with suppliers to drive quality (e.g. clarification of specification, additional quality requirements, improved specifications)
• Initiate and drive periodic Quality Review meetings with (critical) suppliers.
• Support Production, Product Quality Engineer and Incoming Engineer for proper resolution of parts attributed to poor supplier quality, including CAPA review and closure
• Ensure suppliers conduct failure analysis and give prompt and comprehensive resolution for defective parts (factory and fields)
• Analyze and drive appropriate actions to reduce/eliminate Field Installation and Warranty defectives
• Support all Continual Improvement initiatives/ activities to improve KPIs
• Ensure compliance of operations within area of concern with all relevant EHS regulatory requirement and Company safety policies, procedures and guidelines
• Degree in Mechanical Engineering with at least 5 years’ experience in quality assurance/ supplier quality in a manufacturing environment or regulated industry such as medical devices manufacturing.
• Strong knowledge in managing suppliers including supplier evaluation and supplier audits
• Experience with root cause analysis, FMEA
• Ability to read technical drawings and familiar with Measurement system Analysis
• Must have ISO 9001 working knowledge. Familiar with ISO16949, 13485 and FDA QSR.
Please contact Ewen Poh at +65 6950 0365 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1550486
Only successful candidates will be notified.