Production Manager / Site Lead
On-site · Half Moon Bay, California, United States
Job Summary
Production Manager & Site Lead for the Half Moon Bay, CA facility, accountable for safe, compliant, and efficient production operations; partner with onsite engineering to align production with NPI timelines; lead production staff and manage workflow, scheduling, and KPIs (safety, quality, delivery, cost); ensure readiness of work instructions, tooling, and training; drive CAPA and root-cause analyses; support NPD transfer to production and coordinate with the Houston facility as needed; ensure compliance with Cal/OSHA, FDA QSR, and ISO 13485; oversee facility, equipment, and maintenance readiness; lead process-improvement initiatives.
Required Qualifications
- Bachelor’s degree in Engineering, Manufacturing, or related field
- 7–10 years of manufacturing experience in regulated industry
- 3–5 years leadership experience
- Familiarity with MES and ERP systems
- Knowledge of FDA QSR and ISO 13485
- Familiarity with California safety and environmental regulations
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