Senior Quality Systems Specialist

2 weeks ago


Singapore Baxter Full time

Baxter, a leading medical innovation company, is seeking a Senior Quality Systems Specialist to support the development and implementation of quality systems ensuring compliance with regulatory requirements. This role will drive Corrective Action and Preventive Action (CAPA) initiatives, lead internal audits, and collaborate with cross-functional teams to ensure site readiness for external audits.

About Us

We are a global healthcare leader committed to saving and sustaining lives. With a rich history of pioneering medical innovations, we transform healthcare through our products and therapies. Our team at Baxter shares a sense of purpose and strives to make a positive impact on people's lives worldwide.

Job Description

The ideal candidate will have a Bachelor's degree in Engineering or a related field and at least 6 years of experience in a similar position or position of responsibility in the quality field. A certified lead auditor for ISO13485:2016/MDSAP is preferred. The successful candidate will possess strong knowledge of quality system requirements, including FDA 21CFR Part 820, European Medical Device Directive, and ISO13485 Quality System Standards.

Key Responsibilities:
  • Drive CAPA initiatives to identify and correct quality issues
  • Lead internal audits to ensure site compliance with regulatory requirements
  • Collaborate with cross-functional teams to ensure site readiness for external audits
  • Analyze data to identify trends and areas for improvement
  • Develop and implement corrective actions to address quality issues
Requirements:
  • Bachelor's degree in Engineering or a related field
  • At least 6 years of experience in a similar position or position of responsibility in the quality field
  • Certified lead auditor for ISO13485:2016/MDSAP (preferred)
  • Strong knowledge of quality system requirements, including FDA 21CFR Part 820, European Medical Device Directive, and ISO13485 Quality System Standards
  • Excellent analytical and problem-solving skills

Estimated salary: $110,000 - $140,000 per year.



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