Director of Quality - Medical Devices

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San Jose, CA
$180,000 - $200,000
Job Type
Direct Hire
Oct 12, 2018
Job ID
Highly regarded medical device design and manufacturing site seeks a Director of Quality Assurance to lead a site wide quality team at the company's flagship site in the south San Francisco Bay Area.  The focus on responsibilities will be to develop, implement and manage the site's quality systems.  

The Director of Quality will:
  • Support all quality assurance activities which will include: Risk management, FMEAs, hazard analysis.
  • Support and or manage validation activities including IQ, OQ, PQ
  • Manage comprehensive audit program including supplier network, supplier audits, internal audits as well as any FDA or other notified body contact
  • Serve as subject matter expert for the application of design controls per regulatory expectations
  • Provide guidance, recommendations, and implementation plans to ICL procedures and regulatory requirements related to Design Controls, Risk Management, Quality Engineering, system regulation, standard medical device ISO and MDR
  • Manage the Non-conforming Materials Review (NCMR) 
  • Manage Incoming Quality Control activities to ensure timely inspection, including First Article Inspections
  • Oversee other applicable quality elements and programs
  • Bachelor's degree in a technical discipline, such as engineering, life sciences
  • 7+ years progressive experience in the medical device industry
  • Experience with the design and development of Class III implantable medical devices
  • Experience with a variety of complex medical devices, not one product or program.
  • A complete and expert understanding of medial device industry regulatory requirements including FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) and MDR.
  • Strong working knowledge of Design Controls, Risk Management and manufacturing process controls is
  • Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing inspection procedures
  • Some background and knowledge in medical device software preferred
  • Excellent communications skills and the ability to connect at all levels within the organization
  • A track record of accomplishment in managing a complex quality assurance program of significant size and scope
  • Strong analytical and statistical skills