Production Manager
Listed on 2026-08-05
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Manufacturing / Production
Production Manager, Regulatory Compliance Specialist
Production Manager
We are seeking an experienced Production Manager to lead day-to-day manufacturing operations in a regulated, high-volume environment. The role is responsible for ensuring safe, compliant, and efficient production by driving performance against KPIs, managing and developing frontline teams, resolving operational and personnel conflicts, and maintaining strict adherence to quality and regulatory requirements. The ideal candidate will have strong experience in compliance and employee management and a track record of optimizing throughput in fast-paced manufacturing settings.
Key Responsibilities
- Oversee daily production activities to meet output, quality, safety, and on-time delivery targets in a high-volume manufacturing facility.
- Ensure full compliance with applicable regulatory standards (e.g., FDA, ISO) and internal policies; lead audits, documentation control, and corrective actions to maintain certification and regulatory readiness.
- Establish, monitor, and drive production KPIs (OEE, yield, scrap, throughput, on-time delivery) and implement continuous improvement initiatives to improve efficiency and reduce cost.
- Lead, coach, and develop supervisors and operators; manage workforce planning, training, performance reviews, and disciplinary actions to build a high-performing team.
- Resolve operational and interpersonal conflicts promptly and constructively, using proven conflict-resolution techniques to maintain productive working relationships.
- Coordinate with quality, maintenance, engineering, and supply chain functions to troubleshoot production issues, implement root-cause corrective actions, and prevent recurrence.
- Manage changeovers, line balancing, and capacity planning to optimize throughput while maintaining product integrity and traceability.
- Drive safety programs and enforce environmental, health, and safety policies to maintain a safe workplace and minimize incidents.
- Prepare and present regular production reports and metrics to senior management, identifying trends, risks, and recommended actions.
- Support new product introductions and process validations, ensuring production readiness and compliance with regulatory and quality requirements.
Qualifications
- Bachelors degree in Engineering, Manufacturing, Operations Management, or related field, or equivalent experience.
- 5+ years of progressive manufacturing leadership experience, including direct experience in high-volume production environments.
- Demonstrated experience managing compliance in regulated industries (e.g., medical device, pharmaceutical, or similar) including audit management and corrective action systems.
- Proven ability to manage, motivate, and develop hourly and salaried manufacturing teams; strong employee management and coaching skills.
- Experience setting, tracking, and improving KPIs to meet production and quality targets.
- Strong conflict-resolution skills with experience handling performance and behavioral issues fairly and effectively.
- Practical knowledge of production planning, lean/manufacturing methods, root-cause analysis, and continuous improvement tools (e.g., 5S, Kaizen, Six Sigma).
- Excellent communication, leadership, and problem-solving skills; ability to work cross-functionally and manage multiple priorities.
- Nice to have: hands-on experience with plastic injection molding processes.
- Nice to have: prior experience in medical device or pharmaceutical manufacturing and familiarity with related regulatory requirements (e.g., FDA, ISO 13485).
Benefits
- Vacation/PTO
- Medical
- Dental
- Vision - 401k
For this position you must be currently authorized to work in the United States. We do not sponsor for this position.
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