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Director of Quality Assurance

Santa Rosa, CA

Job ID: 111193 Industry: QA/QC Pay Rate: $120000.00/year
Director of Quality Assurance and Regulatory Affairs
Santa Rosa, CA

Salary: $100 120k DOE

Our client is seeking a Director of Quality Assurance and Regulatory Affairs with 5+ years of Quality Assurance and Regulatory Affairs experience supporting a manufacturing company. Your responsibilities will vary from developing & implementing QA strategies, leading internal & external audits, using best practices and providing expertise in regulation, agency guidelines & internal policies, monitoring production & quality control areas, and overseeing projects involving document control, document packages, reviewing labeling materials, ensuring products are compliant, approving submission and test protocols, and risk management.
You re able to work Monday Friday, This is a Direct Hire position with full medical, dental, and 401k.
You re good at:
  • FDA medical device regulations, guidance, and import/exports requirements
  • European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
  • Medical device labeling and promotional requirements
  • Product development process, design control and Quality Systems
  • Technical knowledge of medical device products

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