Our client, a vertically integrated contract manufacturer serving the orthopedic and cardiovascular markets, is seeking a Quality Manager to lead internal and supplier quality systems. The company is known for its rapid prototyping, cleanroom production, and precision machining of implants and surgical instrumentation. This position offers the opportunity to drive end-to-end quality initiatives in a growing environment with strong leadership visibility.

Responsibilities:

• Lead and improve ISO 13485 and FDA 21 CFR 820-compliant quality systems
• Oversee risk management, CAPA systems, customer complaints, and nonconformances
• Develop and manage internal/external audit readiness and supplier quality programs
• Drive process validation, GR&R, and lean improvements across operations
• Interface with R&D, manufacturing, and regulatory functions
• Promote and mentor a culture of continuous improvement and quality discipline

Requirements:

• Bachelor’s degree in engineering, quality, or related technical field
• 8+ years in a medical device manufacturing environment
• Working knowledge of QMS, CAPA, metrology, validation, GD&T, and DOE
• Demonstrated success in audit management, supplier oversight, and quality planning
• Six Sigma certification preferred (Black Belt ideal)

Additional Info:

• Full-time, exempt role with leadership visibility
• Competitive base compensation and performance bonus structure
• Candidates must be eligible to work in the U.S.

This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs.

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