Quality Manager

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

Skills and Requirements

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 ISO9001

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].