Production Manager

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 LSOs 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

• Bachelors 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 LSOs 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

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Full-time