Quality Engineering Manager

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This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $170,000.00/yr

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Sr. Recruitment Consultant - Medical Device | QA/RA | Clinical | SF Bay Area

Quality Engineering Manager – Medical Device - Onsite

We are seeking a highly skilled Quality Engineering Manager to lead a small team in support of commercial catheter products within a regulated medical device environment. This role will oversee quality engineering functions including supplier quality, validation, environmental monitoring, and inspection activities.

Key Responsibilities:

• Lead and develop the Quality Engineering team, providing guidance on quality systems and regulatory compliance (FDA QSR, ISO standards).
• Manage CAPAs, non-conformances, and drive continuous improvement initiatives.
• Oversee process and test method validation efforts.
• Support internal and external audits, including regulatory inspections.
• Collaborate cross-functionally to support production, R&D, and improvement projects.
• Drive lean initiatives and operational excellence.

Qualifications:

• BS in Engineering or Life Sciences; 4+ years of relevant experience.
• Strong knowledge of QMS, statistical analysis, and quality tools (SPC, DOE, gage R&R).
• Experience with test method development, process validation, and improvement projects.
• Prior experience in medical device or a similarly regulated industry (pharma OK; not automotive).
• Strong technical writing and communication skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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