PRODUCTION SUPERVISOR – CLEAN ROOM
Medical Device Manufacturing
We are seeking an experienced Production Supervisor to lead clean room manufacturing operations in a highly regulated medical device environment. This role is responsible for supervising daily production activities, ensuring compliance with FDA regulations and ISO standards, and driving continuous improvement initiatives. The ideal candidate brings at least 5 years of experience in a regulated manufacturing environment and a demonstrated track record of leading high-performance production teams.
- Supervise and direct clean room production staff across assigned shifts, ensuring adherence to SOPs, GMP/GLP guidelines, and ISO 13485 quality standards.
- Monitor production schedules and output targets; identify and resolve bottlenecks to maintain on-time delivery.
- Enforce clean room protocols including gowning procedures, environmental monitoring, and contamination control measures.
- Partner with Quality Assurance to investigate non-conformances, initiate CAPAs, and implement corrective measures.
- Conduct daily shift meetings, performance reviews, and ongoing coaching to develop team members.
- Maintain accurate production records, batch documentation, and deviation reports in compliance with FDA 21 CFR requirements.
- Collaborate cross-functionally with Engineering, Supply Chain, and Regulatory Affairs to support new product introductions and process improvements.
- Lead or participate in internal and external audits; serve as a point of contact for regulatory inspections.
- Drive Lean/Six Sigma initiatives and participate in continuous improvement projects to reduce waste and improve yield.
- Ensure all safety protocols are followed; promptly address and document any safety incidents or near-misses.
- Minimum 3 years of production supervisory experience in a regulated manufacturing environment (medical device strongly preferred; pharmaceutical, aerospace, semiconductor, or other highly regulated industries considered).
- Demonstrated knowledge of FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485.
- Hands-on experience with clean room operations and gowning/environmental control requirements.
- Strong understanding of GMP, SOPs, and documentation practices.
- Proven ability to lead, motivate, and develop a production team.
- Proficiency with ERP/MES systems and Microsoft Office Suite.
- U.S. Citizenship or U.S. Permanent Resident status required.
- 5 years of supervisory experience in medical device or similarly regulated manufacturing.
- Experience with ISO Class 7 or Class 8 clean rooms.
- Lean Manufacturing or Six Sigma certification (Green Belt or higher).
- Background in electromechanical or implantable device manufacturing.
- Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or related field.
This position operates primarily within an ISO-classified clean room environment. Candidates must be willing to adhere to all gowning and contamination control procedures. Ability to stand for extended periods and lift up to 30 lbs may be required. Schedule may include rotating or off-shift hours depending on production needs.
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