Quality Manager
Listed on 2026-10-25
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Quality Manager
Required Skills & Experience Must-Have:
Medical device manufacturing experience
Experience with ISO 13485
Experience with ISO 9001 and quality system expansion is a plus because we will eventually work towards ISO
9001
Strong background in process validation and qualification
Understanding of IQ/OQ/PQ Risk management and change management experience
Bachelor's degree in an Engineering, Biomedical, Biological, Chemical, Pharmaceutical, or related technical discipline.
Job Description Quality Manager supporting the MCX facility, with a strong focus on medical device manufacturing quality systems, process validation, and leadership. The role will initially be dedicated to MCX for approximately six months before expanding to broader organizational quality initiatives. The position reports to Ernie (Director of Operations at the Snoqualmie Facility) with a dotted-line relationship to Lamont (Global Director Quality & Regulatory Affairs based out of San Diego).
Location:
MCX facility (Snoqualmie, WA) - Paid relocation available!
Schedule:
4x10s, approximately 6:00 AM - 4:30 PM with some flexibility
What Success Looks Like The hiring manager is prioritizing candidates who can:
Lead and enhance Quality Management Systems Drive process validation and qualification activities Support significant new product introduction (NPI) growth over the next three years Act as a quality leader across production, engineering, operations, and customer-facing activities Serve as the primary contact for customer audits, regulatory matters, and compliance initiatives
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