Senior Quality Director - Medical Device, Bioengineering - Kingston, Ontario Canada - 18455



JOB DESCRIPTION

Job #: 18455
Title: Senior Quality Director - Medical Device, Bioengineering
Job Location: Kingston, Ontario - Canada
Employment Type:
Salary: $150,000.00 - $180,000.00 - Canadian Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Our client, a rapidly expanding biotech company, is looking for a seasoned quality director to lead their quality department. They are looking for ambitious change managers who are able to see the bigger picture. Full relocation to Kingston, ON is offered.

JOB DESCRIPTION

  • QC / QA responsibility, ensuring company is compliant with GMP/ISO 9001 and 13485
  • In charge of customer on-site audits, setting up supplier quality programs, supporting R&D, and planning strategy for global process development and controls
  • Interacting with global gene therapy and cellular therapy, while partnering with personalized medicine units
  • Company wide safety education and compliance

QUALIFICATIONS

  • Minimum of BSc in a life science related field
  • Proven experience in key leadership role
  • 10 years in manufacturing of either medical device (FDA class II or above). Experience with cell-based biologics, medical equipment, or analytical/diagnostic instruments an asset
  • Interacting with external and internal stakeholders, clients
  • Knowledgeable in USFDA 21CFR820 - documentation, facilities design, supply chain, audits, training, clean room ISO, failure modes and effects analysis (FMEA)

    This is a great opportunity to join a company with a bright future and work on some cutting edge products, if interested please hit apply or send an email to michaelevans@goldbeck.com

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