Senior Quality Assurance Specialist

7 days ago


California, Missouri, United States Twist Bioscience Full time
Lead Quality Engineer Position

The Senior Quality Assurance Specialist - Supplier Compliance will provide critical expertise in ensuring the compliance of supplier controls with applicable regulations and standards. They will lead cross-functional teams, manage internal CAPAs, and conduct high-visibility supplier audits.

About the Role
  • Owning supplier quality processes including supplier controls, global supplier selection, evaluation, and re-evaluation as a corporate business process owner.
  • Leading weekly supplier quality team meetings with cross-functional stakeholders to discuss supplier quality metrics and status.
  • Collaborating with regulatory affairs and quality systems teams to stay up-to-date on the latest regulations and standards.
  • Leveraging ISO 13485:2016 lead auditor certification to ensure supplier quality compliance.
  • Serving as a technical custodian of supplier data monitoring and analysis to drive informed decision-making.
What We're Looking For
  • A bachelor's degree in chemistry, biochemistry, molecular biology, biomedical engineering, drug development & product management, or a related scientific discipline.
  • 5+ years of QA experience working in the drug or medical-device regulated industry.
  • Strong knowledge of supplier qualification activities, good manufacturing practices, and regulatory requirements.
  • Experience leading cross-functional teams, mentoring team members, and making trade-off decisions.

This is an excellent opportunity for a highly skilled and motivated individual to join our team at Twist Bioscience. If you are passionate about quality assurance and supplier compliance, we encourage you to apply. Our estimated salary range for this position is $120,000 - $160,000 per year, depending on experience.



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