Production Manager

Lead the Production Floor Behind Life-Saving Medical Devices

At Life Science Outsourcing (LSO), the medical devices we contract manufacture end up helping real patients in real procedures. The Production Manager is the operational leader who makes that happen on our Brea, California cleanroom floor: planning the work, directing the team, and continuously improving how we deliver on customer commitments, quality standards, and financial targets.

This is a hands-on leadership role for someone who can hold a schedule and a team to a high standard at the same time. You will lead group leaders and production employees, partner across Engineering, Quality, Supply Chain, and Customer Service, and build a culture where accountability, precision, and compliance are simply how the floor runs.

What You’ll Do

Operating within an FDA-regulated, ISO 13485-certified cleanroom environment, you will own daily production performance from the schedule all the way through to the people and the customer relationship.

Production Planning and Scheduling

• Own the daily and weekly production schedule across all cleanroom and ancillary work centers, setting work order priorities to meet on-time delivery.
• Run rough-cut capacity analysis to support workforce planning, work center loading, and bottleneck identification before delivery dates are at risk.
• Partner with Supply Chain and Purchasing on material availability, and escalate shortages proactively.
• Review MRP outputs, reorder reports, and planning tools daily, translating system signals into actionable scheduling decisions.
• Maintain and communicate a visible daily production matrix covering work order status, priority changes, and escalation triggers.

Operational Execution and Continuous Improvement

• Direct production to hit KPIs including on-time delivery, throughput, cycle time, scrap rate, and labor efficiency.
• Lead root-cause analysis and corrective action for flow failures, recurring quality escapes, and schedule misses.
• Drive continuous improvement using Lean principles: 5S, standard work, visual management, and waste elimination.
• Review production data and equipment availability trends, and present operational performance summaries to the General Manager on a regular cadence.
• Collaborate cross-functionally to resolve product, process, and delivery issues with speed and accountability.

People Leadership and Development

• Lead, coach, and develop Production Group Leaders with clear expectations, regular one-on-ones, reviews, and structured feedback.
• Own the floor staffing model in partnership with HR: workforce planning, headcount requests, temp-to-perm decisions, and shift structure.
• Oversee orientation, on-the-job training, and ongoing skills development, and keep training records compliant with the quality system.
• Manage performance concerns, discipline, and employee relations issues with HR, consistent with company policy and California labor law.
• Build a culture that treats safety, quality, precision, and continuous improvement as non-negotiable standards.

Quality and Regulatory Compliance

• Ensure all production complies with FDA 21 CFR Part 820, ISO 13485, and applicable SOPs and work instructions.
• Maintain cleanroom compliance by enforcing gowning, environmental monitoring response, and contamination-control requirements.
• Serve as a production representative in internal and external audits, keeping the floor audit-ready at all times.
• Initiate, review, and approve NCRs, deviations, and CAPA records, and verify corrective actions for effectiveness.
• Ensure batch records, work order travelers, and production documentation are accurate, on time, and document-control compliant.

Customer and Stakeholder Engagement

• Act as an operational point of contact for customer delivery inquiries, status updates, and schedule changes, alongside Customer Service and Program Management.
• Build strong customer relationships through proactive communication on production status, shortages, and commitments.
• Represent LSO's manufacturing capabilities as the production subject matter expert in customer visits, audits, and business reviews.

Safety

• Champion a safety-first culture, ensuring required training, proper PPE, and adherence to Cal/OSHA Title 8 and LSO policies.
• Conduct regular safety walks and promptly remediate unsafe conditions, near-misses, and non-compliant behaviors.
• Partner with EHS and HR to investigate injuries and incidents and track corrective actions to prevent recurrence.