Quality Systems Lead

1 week ago

Singapore beBeeQualification Full time $90,000 - $120,000
Job Description

As a Quality Systems Lead for medical devices, you will be responsible for ensuring the development and implementation of quality systems that meet regulatory requirements.

You will lead cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance.

  • Develop and implement quality management systems based on ISO standards.
  • Lead audits, CAPAs, NCMRs, and complaint handling systems.
  • Implement Supplier Change Requests and utilize Production Part Approval Process (PPAP).
  • Collaborate with Procurement, Manufacturing, and R&D on New Product Development (NPD) projects.
  • Ensure supplier quality systems adhere to all applicable regulations and standards.
Required Skills and Qualifications

To be successful in this role, you will need:

  • Bachelor's degree in Science or Engineering, with advanced degree preferred.
  • At least 8 years of experience in manufacturing quality/engineering quality/supplier quality in the medical device industry, with active medical device experience preferred.
  • Solid experience/knowledge of quality process management and tools, such as APQP, PPAP, SPC, process validation, and statistics.
  • Proficiency in multi-tasking and working in a high-paced, matrixed environment.
  • Able to lead and influence cross-functional teams, including Procurement, Regulatory Affairs, Technical Services, and Research & Development.
Benefits

This role offers:

  • Opportunity to work with a leading medical device company.
  • Chance to develop and implement quality systems that make a real impact on patient safety.
  • Cross-functional team collaboration and leadership opportunities.
Others

Please note that this is a full-time position requiring at least 20% travel.

We are an equal opportunity employer and welcome diverse candidates.

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