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Sr. QA Manager

Sr. QA Manager

Innovative Career ResourceIrvine, CA
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Sr. Quality Systems Manager

Join a globally recognized leader in Orange County, CA, and play a key role in advancing world-class quality systems at a company driving the future of healthcare innovation.

We’re looking for a  Sr.  Quality Manager to oversee our Quality Systems, including the Quality Assurance and Technical Investigations Group (TIG). This is a high-impact role where you’ll lead a talented team and champion initiatives that ensure excellence across every facet of our operations.

Just a snapshot of what you will  manage :

  • Final product release
  • CAPA programs
  • QMS document control
  • Validations
  • Internal & external audits
  • Complaints  & change  notifications
  • Non-conformances

K ey Responsibilities – Quality Leadership Role :

  • Lead and manage all aspects of the Quality Systems, ensuring compliance and continuous improvement.
  • Serve as a subject matter expert on quality regulations, including GMP and ISO standards.
  • Oversee and direct preparation for FDA and Notified Body inspections, acting as the primary quality liaison.
  • Coordinate and host internal and external audits, ensuring audit readiness and successful outcomes.
  • Drive and support product, process, and quality system improvement initiatives across the organization.
  • Deliver training and hands-on coaching on Quality System Regulations, ISO standards, and compliance best practices.
  • Develop and lead the Quality Systems team — including hiring, mentoring, performance management, and growth planning.
  • Monitor and analyze Quality Indicators and KPIs, providing actionable insights and leading effective CAPA strategies for ongoing improvement.

    • What We're Looking For – Must-Have Qualifications :

  • Bachelor’s Degree
  • Auditor experience – at least 1 year preferred
  • Hands-on experience in a regulated medical device manufacturing environment
  • Solid understanding of U.S. and international medical device regulations, including :   21 CFR 820, 803, 804 ( MDR ) ,  ISO 13485, ISO 14971, ISO 13408 ,  EU  MDR  2017 / 745 / MDD 93 / 42 / EEC ,  Canadian and Brazilian Medical Device Regulations
  • Formal training in quality tools such as  CQE ,  CQA , Six Sigma, Risk Assessment, FMEA, FTA, DOE, and Statistical Techniques .
  • Experience with validation of processes and equipment, method validations, process investigations, and technical evaluations .
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