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

[email protected]

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