Director of Quality - Quality Management Representative, Medical Devices Job at Cambridge Recruiters, San Jose, CA

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  • Cambridge Recruiters
  • San Jose, CA

Job Description

Director of Quality - Quality Management Representative

Well-Funded 25-Person Start-up Medical Device company

Devices: Neurovascular & Endovascular devices (US Market, 510K)

Location: San Jose, CA (near SJ Airport)

Responsibilities:

  • Will serve as the company's first Quality Management Representative
  • Draft and manage a complete QMS
  • Own and ensure Quality Compliance for the company
  • FDA & ISO Audits
  • Incoming & Receiving Inspections
  • CAPA & NCR
  • Supplier Audits
  • Write and revise SOP's, WI's
  • Will establish the Quality function at the company, and soon add a small support team (likely Doc Control and/or Quality Specialist or Manager)

Requirements:

  • **Must Have served as a Quality Management Representative**
  • BS Degree, preferred in an Engineering or Lifesciences discipline
  • 10-15+ years Quality Assurance experience in a MEDICAL DEVICE company
  • 5+ years People Leadership experience
  • Startup experience preferred, or mix of startup & larger company experience
  • Hybrid Position: Requirement to be in-office 3 days/week (variable or set schedule)
  • Must Have US Work Authorization (No H1B Visa or Green Card Sponsorships)
  • Local Candidates only - SF Bay Area. No relocation assistance available.
  • Interventional Catheter-based Vascular Class II or Class III device experience preferred

Title & Salary are flexible based on the candidate (Market Rate)

This is a high priority position and will serve as an integral part of the Senior Leadership Team.

Recruiting Contact:

Jim Smith

Cambridge Recruiters

jim@cambridgerecruiters.com

Job Tags

Local area, Relocation, Work visa, H1b, Flexible hours, 3 days per week,

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