Rotate Device

Job Openings

Senior Engineer, Supplier Quality Assurance

Quality Assurance
Job Description

Main Purpose of Job

This position is responsible for end-to-end supplier management, which includes oversight of supplier sourcing and selection process, as well as the qualification (audit), monitoring, development, and decommissioning of suppliers.


Role and Responsibilities


  • Lead and audit suppliers of material and services onsite. (e.g., molding supplier, CROs, warehouse, contract testing laboratory, Software supplier)
  • Issue audit reports and follow up on audit results, including any non-conformances and CAPA implementation


Audit/Supplier Management

  • Develop the Annual Global Supplier Audit plan and perform periodic supplier re-evaluation based on supplier risk
  • Manage and update Global Approved Supplier List (ASL)
  • Provide oversight of supplier assessments, escalate issues and lead risk assessments and mitigations, as appropriate
  • Develop and negotiate Quality Agreement with suppliers


Supplier Issue Investigation/Resolution

  • Participate in Material Review Board to ensure that non-conforming product/s is/are properly investigated and dispositioned
  • Work with suppliers to correct non-conformances
  • Identify, initiate, and drive Supplier Corrective Action Reports (SCAR) response to ensure effectiveness of corrective and/or preventive actions implemented


Supplier Performance Monitoring

  • Lead the monthly Global Supplier Quality Performance Review meeting and closely monitor supplier's performance. Take appropriate action on suppliers to improve quality performance
  • Ensure supplier’s quality systems are aligned with current regulatory requirements, HOYA Surgical Optics (HSO) requirements and applicable standards
  • Prepare QA metrics and participate in Quarterly Business Review (QBR) and Annual Performance Vendor review with suppliers and vendor management team


Change management and projects

  • Ensure timely evaluation of Supplier Change Notification and initiation of change control process where applicable
  • Support Supplier Development initiatives and implement supplier quality related improvement program
  • Develop and/or revise Global SOP, Work Instructions and other supplier related documentations



  • Bachelor’s degree or Diploma in Science or Engineering



  • Minimum 5-7 years of experience in medical device, bio/pharmaceutical industry
  • Experience in supplier quality management preferred



  • Demonstrated working knowledge in ISO 9001 / ISO 13485, QSR Part 820, Medical Device Regulation (MDR)
  • Knowledge of Supplier Quality Management principles
  • ISO 9001/ISO 13485 Lead Auditor certification preferred
  • Demonstrated knowledge and experience of Statistical Process Control (SPC) and Risk Management tools such as FMEA, Process Mapping, Hazard Analysis, MSA
  • Good knowledge in molding highly preferred
  • Demonstrated knowledge and/or experience in supply chain management, supplier development, risk management and training
  • Basic knowledge of product inspection and test techniques
  • Good interpersonal skills and ability to influence people without direct authority
  • Proactive and flexible in adapting to changing environment
  • Able to manage and prioritize work with tight timelines
  • Able to effectively influence and negotiate with suppliers and successfully lead change initiatives


Travel Requirement

  • Approximately 10-20% locally and regionally


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We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.



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