Director/Senior Director Quality Assurance & Regulatory Affairs
Will serve as the Head of QA/RA and Quality Management Representative reporting to a COO.
Scope: Quality Engineering & QMS + Regulatory Affairs strategy, 510K submissions and international registrations.
Lead a team of Quality Engineers & Regulatory Specialists (5-10 Direct Reports)
** Need a good mix of Quality & Regulatory experience (not just strong in one and light in the other).
Class II Medical Device products: plastic Injection molded components and mechanical/electro-mechanical systems.
This is an On-Site position, with some flex-hybrid days that can be worked from home.
No fully-remote or commuting candidates please. Must either reside in the Seattle area, or be willing to relocate.
The company has been around over 10+ years, and has multiple products on the US Market.
They have a new device to be launched in the US and OUS later this summer/fall.
Requirements:
Full-Time Permanent position
Full Benefits
Relocation offered for well-qualified candidates
Must be a US Citizen or have US Work Authorization. No Visa Sponsorships available.
Qualified Candidates will be screened within 24 hours of application
Recruiting Contact:
Jim Smith - Cambridge Recruiters
jim@cambridgerecruiters.com
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