Sr. Production Supervisor
Position Summary
The Sr. Production Supervisor will lead daily manufacturing operations, ensuring that production output, quality, and compliance goals are consistently met in a regulated medical device environment. This role will supervise production teams, oversee workflow planning, enable cross‑functional collaboration, and drive continuous improvement initiatives that support operational excellence and product reliability.
Key Responsibilities
- Provide day‑to‑day leadership, coaching, and performance management for production technicians and leads.
- Oversee production schedules, staffing levels, material availability, and resource allocation to meet operational targets.
- Ensure compliance with all applicable medical device regulations, including GMP, ISO 13485, and FDA Quality System Regulations.
- Work closely with Quality, R&D, Engineering, and Supply Chain to resolve production issues, support new product builds, and ensure smooth process transitions.
- Maintain rigorous documentation practices, including batch records, travelers, device history files, and equipment logs.
- Ensure production equipment is properly maintained, calibrated, and ready for daily operation.
- Lead Lean, 5S, and continuous improvement initiatives to increase throughput, reduce waste, and enhance process consistency.
- Support root‑cause investigations, CAPA activities, and process improvement projects in partnership with engineering and quality teams.
- Promote a culture of safety, engagement, and accountability across the production floor.
Qualifications
- Bachelor's degree in engineering, operations, manufacturing, or a related discipline (or equivalent practical experience).
- 5+ years of experience in medical device manufacturing or a similarly regulated environment, with 2+ years in a supervisory role.
- Proven leadership ability with experience directing and developing production teams.
- Excellent communication, organizational, and problem‑solving skills.
- Demonstrated success improving operational processes and supporting technically complex production workflows.
Preferred Skills
- Prior work in early‑stage, scaling, or high‑growth medical device organizations.
- Familiarity with ERP/MRP systems and electronic documentation/quality platforms.
FAQs
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