Clean Room Manager

Salary: $130,000 - $145,000

Location: Los Angeles, CA

Position Summary

We are seeking a highly motivated and hands-on Clean Room Manager to lead all aspects of clean room manufacturing operations within a regulated medical device manufacturing environment. This individual will be responsible for overseeing daily production activities, ensuring compliance with quality and regulatory requirements, driving operational excellence, and developing high-performing teams.

The ideal candidate will possess extensive experience in clean room manufacturing, medical device production, injection molding, assembly, packaging, and quality systems. This role requires a manager who is comfortable balancing strategic leadership with direct involvement on the production floor to resolve issues, support teams, and ensure customer commitments are met.

Key Responsibilities

Operations Management

• Direct and supervise all clean room manufacturing activities, including molding, assembly, inspection, packaging, and related operations.
• Lead daily production meetings and establish priorities to meet customer demand, quality requirements, and production schedules.
• Monitor production performance metrics including safety, quality, delivery, scrap, downtime, labor efficiency, and overall equipment effectiveness (OEE).
• Ensure timely execution of manufacturing schedules while maintaining compliance with established procedures.
• Actively support production teams by troubleshooting operational, quality, and equipment-related issues.
• Coordinate resources, staffing levels, and workflow to maximize efficiency and throughput.

Quality & Regulatory Compliance

• Ensure adherence to all clean room protocols and contamination-control procedures.
• Maintain compliance with applicable FDA regulations, ISO 13485 requirements, GMP standards, and internal quality systems.
• Partner with Quality and Regulatory teams during audits, inspections, validations, and customer visits.
• Investigate quality concerns, non-conformances, CAPAs, and customer complaints.
• Drive continuous improvement efforts to reduce defects, improve yields, and enhance product quality.

Leadership & Team Development

• Lead, coach, mentor, and develop supervisors, leads, technicians, and operators.
• Conduct performance reviews, establish goals, and implement employee development plans.
• Foster a culture of accountability, teamwork, safety, and continuous improvement.
• Manage staffing plans, hiring activities, onboarding, and workforce development initiatives.
• Ensure employees are properly trained and qualified for assigned responsibilities.

Process Improvement

• Identify opportunities to improve manufacturing processes, productivity, and quality performance.
• Utilize Lean Manufacturing, Six Sigma, Kaizen, and other continuous improvement tools to eliminate waste and optimize processes.
• Support process validations, equipment qualifications, and new product introductions.
• Collaborate with Engineering, Maintenance, Tooling, and Quality departments to implement process improvements.
• Analyze production data and implement corrective actions to achieve operational goals.

Safety & Environmental Compliance

• Promote a strong safety culture throughout all manufacturing operations.
• Ensure compliance with company safety policies and applicable regulations.
• Lead investigations related to safety incidents and implement corrective actions.
• Maintain a clean, organized, and compliant manufacturing environment.

Qualifications

Required

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or related field; equivalent experience may be considered.
• 5+ years of leadership experience in a clean room manufacturing environment.
• Experience managing medical device, life sciences, pharmaceutical, or highly regulated manufacturing operations.
• Strong knowledge of clean room procedures and contamination-control practices.
• Experience with FDA-regulated manufacturing and ISO 13485 quality systems.
• Proven success leading production teams in a fast-paced manufacturing environment.
• Demonstrated experience with root cause analysis, CAPA management, and continuous improvement initiatives.
• Strong problem-solving, communication, and leadership skills.

Preferred

• Experience with medical injection molding, silicone molding, overmolding, or medical device assembly operations.
• Lean Manufacturing and/or Six Sigma certification.
• Experience supporting audits from customers, regulatory agencies, and certification bodies.
• Knowledge of process validation, equipment qualification, and product transfer activities.
• Experience managing multiple shifts and large manufacturing teams.

Key Competencies

• Hands-on leadership
• Team development and coaching
• Clean room manufacturing expertise
• Medical device manufacturing knowledge
• Operational excellence
• Regulatory compliance
• Continuous improvement
• Problem solving and decision making
• Cross-functional collaboration
• Safety leadership

Work Environment

• Primarily based within a clean room and manufacturing environment.
• Frequent interaction with production personnel, engineering, quality, maintenance, and senior leadership teams.
• Must be comfortable spending significant time on the production floor supporting employees, troubleshooting processes, and driving operational improvements.
• May occasionally support off-shift operations, customer visits, and audit activities as business needs require.