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Healthcare & Life Sciences

Senior Supplier Quality Engineer (Life Sciences Manufacturing MNC)

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HLS/KP/SSQE/231019C
Posted: 22 days ago
Consultant: Kelvin Pang
Consultant Email: email Kelvin
Consultant Phone: +65 6950 0364

Job description

Responsibilities

  • Manage suppliers to ensure all part quality requirements are met
  • Lead supplier qualification activities for new suppliers with Product Manager, Global Supply Chain, Subject Matter Experts, and/or other cross functional team members
  • 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
  • Drive timely CAPA and customer complaint closure by ensuring suppliers conduct failure analysis and give prompt and comprehensive resolution for defective instrument and/or part failures
  • Ensure suppliers conduct failure analysis and give prompt and comprehensive resolution for defective parts (factory and fields)
  • Analyse 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

Experience

  • Degree in Electrical/ Electro-Mechanical/ Mechanical Engineering with at least 3 years’ experience in quality assurance/ supplier quality experience 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 problem solving tools such as root cause analysis, FMEA
  • Familiar with Statistical Process Controls and Measurement System Analysis
  • Ability to read technical drawings
  • Must have ISO 9001 working knowledge. Familiar with ISO16949, 13485 and FDA QSR

Please contact Kelvin Pang at +65 6950 0364 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1325516

Only successful candidates will be notified.