Production Manager: Medical Device Ops Leader (Lean, ISO/FDA)

LIFE SCIENCE OUTSOURCING INC; Brea (CA); On-site; USD 75,000 - 90,000; Full time

Job summary

Life Science Outsourcing, Inc. in Brea, CA, is seeking a Production Manager to lead the cleanroom floor, schedule work, and drive continuous improvement in a regulated manufacturing environment.

Responsibilities include planning, cross-functional leadership, and ensuring compliance with FDA/ISO13485. This on-site role requires strong supervision, data-driven decision making, and a focus on delivery performance and quality.

Qualifications

• 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 considered.
• Track record of managing production schedules, meeting on-time delivery, and leading teams through performance improvement.
• MRP/ERP experience required; familiarity with Deacom or similar a plus.
• Strong proficiency with Microsoft Excel, Word, and Outlook.

Responsibilities

• Own daily and weekly production schedule across all cleanroom and ancillary work centers to meet on-time delivery.
• Lead root-cause analysis and CAPA for flow failures and schedule misses; drive Lean improvements.
• Develop and coach Production Group Leaders; oversee staffing in partnership with HR.
• Ensure production complies with FDA 21 CFR Part 820, ISO 13485, and related SOPs.
• Engage with customers and program management to communicate status and resolution of issues.

Skills

Production scheduling

Lean manufacturing

Leadership

MRP/ERP

Regulatory compliance

Education

Bachelor's degree in Operations Management/Industrial Engineering/Business Admin

Lean Six Sigma certification (Green Belt or higher)

Tools

Deacom ERP

Microsoft Excel

MS Word/Outlook

Job description

Life Science Outsourcing, Inc. in Brea, CA, is seeking a Production Manager to lead the cleanroom floor, schedule work, and drive continuous improvement in a regulated manufacturing environment.

Responsibilities include planning, cross-functional leadership, and ensuring compliance with FDA/ISO13485. This on-site role requires strong supervision, data-driven decision making, and a focus on delivery performance and quality.