Manufacturing Supervisor
$85,000–$101,000 year
On-siteSan Diego, California, United States
San Diego, California, United StatesOn-siteFull Time$85,000–$101,000 yearSmall
Full TimeSmall
Job Summary
Install, qualify, and validate pilot line equipment and processes while translating engineering documentation into standard operating procedures. Supervise day-to-day operations across shifts, coaching associates, managing inventory, and ensuring compliance with FDA QSR and ISO 13485 regulations. Lead continuous improvement initiatives and drive resolution of process, equipment, and workflow issues to support scale-up from pilot to commercial production. Partner with Engineering, Quality, and Operations to build training programs and documentation for future product lines.
Required Qualifications
- B.S. degree or higher in Operations Management, Engineer, Life Sciences, or a related field
- 5+ years of experience in medical device, pharmaceutical, or other regulated manufacturing environments
- Direct experience supporting new product introduction (NPI), process validation (IQ/OQ/PQ), or pilot-to-production scale-up
- Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 requirements
- Ability to lift and carry up to 25 pounds
- Ability to lift or move up to 50 pounds
- Willingness to work flexible hours, including off-shift or weekend coverage
Desired Qualifications
- Equipment hands-on experience
- Candidates with fewer years in a formal supervisory title who have served as a process/technical lead, informal team lead, or subject matter expert
- Direct experience supporting new product introduction (NPI), process validation (IQ/OQ/PQ), or pilot-to-production scale-up
- Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 requirements
- Direct audit experience
- Comfortable operating with ambiguity and building structure where little currently exists
- Strong troubleshooting and hands-on problem-solving skills in an equipment- and process-driven environment
- Working knowledge of lean manufacturing and continuous improvement methods (5S, root cause analysis)
- Kindness – Treats current staff, technicians, new operators and cross-functional partners with patience and respect, especially when troubleshooting under pressure
- Innovation – Brings creativity and resourcefulness to first of their kind problems that don't yet have a guide or instructions
- Trust – Communicates transparently, follows through reliably, and gives team, colleagues, and leadership confidence in their work and word
- Excellence – Is detailed and accurate in documentation and execution, works to minimize errors, and does more than the minimum required, taking real pride and ownership in the product and the team's work
- A natural collaborator and team player who works effectively across Engineering, Quality, Supply Chain, and Operations Leadership
- Strong coaching and people-leadership instincts, including scheduling and performance management across a growing, multi-shift team
- Ability to build something new and scale it responsibly, balancing speed with the rigor a medical device requires
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.