Operations Quality Manager

About the role

We are looking for a driven and experienced Operations Quality Manager to lead quality engineering and Quality Control functions within our medical device manufacturing operations. This role plays a critical part in ensuring product quality, regulatory compliance, and continuous improvement across the organization.

Responsibilities

• Lead risk management activities (PFMEA, control plans)
• Support product development and design transfer (21 CFR Part 820)
• Develop and validate inspection methods and test protocols
• Analyze quality data (CAPA, NCRs, complaints) and drive root cause investigations
• Partner cross-functionally with Engineering, Manufacturing, and Supply Chain
• Interface with customers on quality issues
• Supervise and develop QC team members
• Oversee incoming, in-process, and final inspections
• Manage nonconforming materials and participate in MRB
• Ensure accuracy of Device History Records (DHRs)
• Improve inspection processes and drive efficiency
• Conduct non-conforming product investigations
• Manage inspection/test equipment lifecycle
• Conduct IQ/OQ/PQ and MSA (Gage R&R) activities
• Support new equipment introduction and automation initiatives
• Ensure compliance with FDA, ISO 13485, ISO 14971
• Support audits and drive timely corrective actions
• Lead structured problem-solving (8D, 5 Whys, Fishbone)
• Champion Lean/Six Sigma improvements

Requirements

• Bachelor’s degree in Engineering, Quality, or related field
• 7+ years of quality experience in medical device or regulated manufacturing
• Strong knowledge of FDA QSR and ISO 13485
• Experience with CAPA, NCRs, inspections, and statistical tools
• Leadership experience or demonstrated team leadership capability
• Strong communication, analytical, and problem-solving skills
• ASQ certification (CQE, CQA)
• Licenses: ASQ certification (CQE, CQA), Lean Six Sigma Green or Black Belt
• Familiarity with ISO 14971 risk management
• Proficiency with statistical software (Minitab, JMP)
• On-site role in a combination of office, manufacturing, and cleanroom environments
• Hands-on involvement with production and inspection processes

Qualifications

• Legal authorization to work in the United States
• This is a fully on-site position (no remote or hybrid option)

Benefits

• Competitive compensation
• Health, Dental, Vision coverage
• FSA
• Life Insurance
• 401k
• Generous PTO
• Paid Holidays