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Quality Assurance Manager

2 months ago

Thousand Oaks, United States Accordance Search Group Full time
  • 100% onsite ; no remote flexibility
  • Looking for ISO 13485 + FDA 21 CFR part 820 experience
  • Regulatory and global experience preferred
  • Engineering experience is a plus
  • Experience with a QMS implementation preferred
  • Must be a great collaborator with strong communication skills
  • Process improvement / Continuous improvement experience
  • Would manage team of 4 (2 FTE’s and 2 contractors) – must have at least 2 years of management experience


Responsibilities

  • Manage the Quality Affairs team
  • Develop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured.
  • Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements.
  • Develop strong partnerships with R&D, manufacturing, marketing, sales and regulatory.
  • Ensure compliance with applicable FDA and ISO requirements.


Qualifications

  • BS in Engineering or Science
  • 8 years relevant experience in a regulated environment (preferably Medical Device)
  • 2 years directly supervising employees in quality