Operations Quality Manager
Martech Medical Products
Operations Quality Manager Martech Medical Products, Inc.
Harleysville, PA On-site | Full-Time
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.
You will lead a team, partner cross-functionally, and ensure adherence to FDA, ISO 13485, and related standards in a cleanroom manufacturing environment. What You'll Do Quality Engineering
Why Join Us
Harleysville, PA On-site | Full-Time
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.
You will lead a team, partner cross-functionally, and ensure adherence to FDA, ISO 13485, and related standards in a cleanroom manufacturing environment. What You'll Do Quality Engineering
- 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
- 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)
- Lean Six Sigma Green or Black Belt
- Experience with ISO 14971 risk management
- Familiarity with eQMS, CSV, and supplier quality
- 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
- Occasional travel as needed
- ✅ Must be legally authorized to work in the United States
- ✅ This is a fully on-site position (no remote or hybrid option)
- ❌ Current or future visa sponsorship is not available
- ❌ Relocation assistance is not available
Why Join Us
- Opportunity to lead quality in a regulated, high-impact environment
- Collaborative, cross-functional culture
- Focus on continuous improvement and innovation
- Career growth and leadership development opportunities
- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Generous PTO
- Paid Holidays
Vacancy posted 1 day ago
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