Production Manager

We are looking for a proactive and enthusiastic **Production Manager** with good positive energy to join our team. 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. **We encourage you to submit a resume with salary requirements.** **Job Description** 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. **Qualifications** **Skills & Experience** - Bachelor's degree in Operations Management, Industrial Engineering, Business Administration, or a related field preferred. An equivalent combination of education and direct production management experience will be considered. - Minimum 5 years of progressive manufacturing experience, with at least 3 years supervising or managing direct reports. - FDA-regulated, ISO 13485-certified medical device experience strongly preferred. Pharmaceutical or other regulated industry experience considered. - Track record of managing production schedules, hitting on-time delivery, and leading teams through performance improvement. - MRP/ERP experience required (familiarity with Deacom or similar a plus), plus proficiency with Microsoft Excel, Word, and Outlook. - Working knowledge of FDA 21 CFR Part 820 and ISO 13485 as they apply to production operations. **Mindset & Impact** - A leader who can develop and hold accountable a multi-level team of leads and hourly employees. - A clear communicator who turns floor realities into data-driven summaries for leadership, Quality, and customers. - A problem solver grounded in Lean, 5S, root-cause analysis, and CAPA. - Able to manage competing priorities in a fast-paced, customer-driven environment without sacrificing documentation quality or compliance. **Nice to Have** - Lean Six Sigma certification (Green Belt or higher) or equivalent structured problem-solving training. - Bilingual in English and Spanish for communication with the production workforce. - Experience leading production through a third-party regulatory audit (FDA, BSI, or equivalent). - Familiarity with cleanroom manufacturing protocols and ISO classification standards. Why Join LSO? - You will lead operations that directly support life-saving medical device manufacturing. - Real ownership: the schedule, the team, the KPIs, and the customer relationship are yours to run. - Differentiated, regulated-industry leadership experience (FDA, ISO 13485) in a growing company. - A culture where safety, quality, and precision are standards, not slogans. Work Environment - On-site at our Brea, CA manufacturing facility. - Ability to stand and walk for extended periods on the production floor and lift up to 30 pounds occasionally. - Regular movement between office, warehouse, and cleanroom manufacturing areas. - Cleanroom entry requires full gowning per LSO contamination-control protocols. - Exposure to chemicals, solvents, and manufacturing equipment. Appropriate PPE is provided and required. - Schedule aligns with production operations, with flexibility required during customer audits, end-of-quarter delivery pushes, or production escalations. Make an Impact The Production Manager sets the pace, the standard, and the tone for the floor that builds devices clinicians and patients rely on. Hit the schedule, develop the team, and protect the quality system, and you keep LSO's promise to its customers and to the patients at the end of the line. If you want a leadership role where operational excellence has a human payoff, this is it. Life Science Outsourcing, Inc. • Brea, CA