Production Supervisor (2nd Shift | 3pm - 11pm PST)

Job title: Production Supervisor (2nd Shift | 3pm - 11pm PST)

About the Role The Production Supervisor oversees day-to-day manufacturing operations, ensuring production schedules are met safely, efficiently, and in compliance with FDA, ISO 13485 and GMP standards. This role leads and develops production teams and collaborates with Manufacturing Engineering, Quality, and Supply Chain to deliver high-quality medical devices that improve patients' lives. This is a 2nd shift role (3pm–11pm PST) at our Orange County site.

What You'll Do

• Supervise daily production operations to meet safety, on-time delivery, and quality specifications.
• Maintain compliance with FDA, ISO 13485, and other medical device regulations.
• Communicate daily goals, priorities, and performance expectations to the manufacturing team.
• Identify and escalate production issues promptly to minimize schedule disruption.
• Lead and motivate manufacturing associates; conduct training to ensure SOPs, Work Instructions, GDP, and GMP compliance; monitor attendance and safety.
• Execute production plans and adjust staffing/resources to meet daily output.
• Ensure proper documentation of production records, deviations, and maintenance activities.
• Partner with planning and supply chain to ensure materials availability and optimized inventory.
• Monitor Plan vs. Actual performance and identify root causes for variances.
• Support nonconformance investigations, CAPAs, and audits as needed.
• Promote GDP and data integrity; maintain a safe, compliant work environment.
• Participate in Lean events, 5S programs, and standardization projects to drive continuous improvement.

What We're Looking For

• Associate degree or equivalent experience; Bachelor's degree in Engineering, Manufacturing, or related field preferred.
• 3–5 years of manufacturing operations experience, with 1–2 years in a supervisory/lead role, preferably in a medical device or regulated industry.
• Demonstrated experience leading small to medium-sized production teams.
• Working knowledge of medical device manufacturing, quality systems (ISO 13485, FDA 21 CFR Part 820), and GMP.
• Familiarity with ERP or MRP systems (e.g., QAD, SAP, Oracle).
• Strong communication, problem-solving, and organizational skills.
• Ability to motivate and lead teams while maintaining accountability for safety, quality, and delivery.
• Commitment to fostering teamwork, employee engagement, and continuous improvement.

Nice to Have

• Bachelor’s degree in Engineering, Manufacturing, or related field preferred.
• Experience in a medical device or regulated environment.
• Lean/Six Sigma familiarity and experience with Lean events, 5S, and standardization projects.

Compensation & Benefits

• Salary not disclosed in the posting.
• This is an on-site role at our Orange County, CA facility with standard manufacturing site benefits; details not provided in the posting.