Lead Production Floor Supervisor - ISO/GMP

NextPhase Medical Devices LLC; Mansfield (MA); On-site; USD 34,000 - 48,000; Full time

Job summary

Arterex Medical in Mansfield, MA seeks a Production Floor Supervisor to lead multiple lines, train staff, and ensure on-time, quality builds. You will drive manufacturing excellence on the floor, work with cross-functional teams, and mentor operators in a fast-paced environment.

The role emphasizes hands-on leadership, adherence to ISO 13485:2016 and 21 CFR 820, and a commitment to safety, documentation, and continuous improvement on the shop floor.

Qualifications

• 5+ years in a regulated manufacturing environment.
• Experience with ISO 13485 and FDA QSR requirements.
• Supervisory experience and training ability.
• Cleanroom assembly experience a plus.

Responsibilities

• Lead production lines to meet schedules with quality.
• Train, assign tasks, and mentor team members.
• Uphold safety and GMP/GDP standards.
• Interpret blueprints and assembly instructions.
• Complete regulatory documentation as required.

Skills

Team leadership

Blueprint interpretation

Troubleshooting

Mechanical aptitude

Electrical aptitude

Soldering

Documentation accuracy

Communication

Education

ISO 13485:2016 experience

FDA QSR 21 CFR 820 familiarity

High School diploma

CPIM / CMS a plus

Tools

Torque tools

Calipers / measurement tools

Wire diagrams

Job description

Arterex Medical in Mansfield, MA seeks a Production Floor Supervisor to lead multiple lines, train staff, and ensure on-time, quality builds. You will drive manufacturing excellence on the floor, work with cross-functional teams, and mentor operators in a fast-paced environment.

The role emphasizes hands-on leadership, adherence to ISO 13485:2016 and 21 CFR 820, and a commitment to safety, documentation, and continuous improvement on the shop floor.