Production Supervisor

About the Organization By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes.

We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

• Accountable for achieving Production targets
• Plan and run the shift production schedule to meet daily, weekly and monthly output targets.
• Assign operators to lines and workstations (film welding/RF and impulse sealing, tubing cutting and assembly, connector and fitting assembly, bag forming, leak and integrity testing, labeling, packaging).
• Monitor line performance, throughput, scrap and downtime in real time; act on deviations from plan.
• Coordinate with Planning, Materials, Warehouse and Maintenance on material availability, line changeovers and equipment readiness.
• Verify line clearance before every lot and product changeover to prevent mix-ups.
• Hand off shift status, open issues and priorities to the next shift in writing.
• Enforce compliance with ISO 13485:2016, FDA 21 CFR Part 820 (Quality Management System Regulation), EU MDR 2017/745 where applicable, and site SOPs and work instructions.
• Ensure every lot is built to the current Device Master Record / Medical Device File and that Device History Records (batch records) are complete, accurate and timely.
• Apply Good Documentation Practices (ALCOA+) on the floor and correct documentation errors at the source.
• Initiate and support nonconformance reports (NCRs), deviations, investigations and CAPAs; lead root-cause work for production-related issues.
• Participate in internal, customer, notified body and FDA audits and inspections; present shift practices and records.
• Support process validation (IQ/OQ/PQ) and change control by releasing operators and equipment for runs and executing protocol steps as assigned.
• Control nonconforming material through quarantine, labeling and MRB disposition.
• Enforce gowning qualification, cleanroom behavior and material transfer procedures.
• Ensure scheduled cleaning and sanitization are done and documented.
• Respond to environmental monitoring (particulate, viable, pressure differential) excursions with QA.
• Protect bioburden and particulate controls on product before sterilization (gamma, e-beam or EtO, typically through a contract sterilizer).
• Hire, onboard, train and qualify operators; maintain the shift training matrix so no one performs a task without current training.
• Set clear expectations, coach, and evaluate employee performance against established goals and performance standards to support individual and team success.
• Manage attendance, overtime, timekeeping and shift staffing levels.
• Build a culture of quality, accountability and open escalation of problems.
• Enforce site EHS rules, PPE, lockout/tagout, machine guarding and ergonomic practices.
• Investigate injuries and near misses, and close corrective actions.
• Lead shift safety talks and support 5S audits.
• Lead or join Lean and Six Sigma projects to cut scrap, cycle time and changeover time.
• Use tier/daily huddle boards to track KPIs and elevate issues.
• Propose process, equipment and work-instruction improvements through change control.
• Keep production records current in ERP/MES (e.g., work order transactions, labor, scrap, inventory moves).
• Review and approve…