Job Overview
The Assembly Supervisor oversees daily assembly operations to ensure medical devices are manufactured safely, efficiently, and in full compliance with quality system regulations. This role leads assembly personnel, enforces Good Manufacturing Practices (GMP), and drives continuous improvement in productivity, quality, and safety.
Responsibilities
- Supervise and coordinate daily activities of medical device assembly technicians
- Ensure compliance with ISO 13485, GMP, and internal quality procedures
- Monitor production schedules and staffing to meet output, quality, and delivery targets
- Train, coach, and evaluate assembly staff on procedures, workmanship standards, and safety
- Review and enforce adherence to work instructions and SOPs.
- Identify and resolve production issues, defects, and process deviations
- Collaborate with Quality, Engineering, and Manufacturing teams to support process improvements and investigations
- Conduct line audits and ensure proper documentation and traceability
- Support continuous improvement initiatives such as Lean, Six Sigma, or 5S
- Maintain a safe, clean, and organized work environment
- Participating in internal and external audits as required
Requirements
- High school diploma or GED required; associate or bachelor’s degree preferred
- 3–5 years of experience in medical device manufacturing or regulated assembly environment
- Previous supervisory or team lead experience
- Ability to read and interpret technical drawings, work instructions, and procedures
- Strong leadership, communication, and problem-solving skills
- Experience with ERP or manufacturing execution systems (MES)
- Familiarity with Lean manufacturing or continuous improvement methodologies
Job Type: Full-time
Pay: $75,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person