The Production Supervisor (PS) leads manufacturing shifts that make single-use medical supplies safely, on schedule and in full compliance with the Quality Management System. The role owns daily shift output, cleanroom discipline, Good Documentation Practices and the development of the production team. It is the first line of accountability for product quality, safety and regulatory readiness on the floor.
Responsibilities:
- 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 escalate 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 completed batch records before transfer to QA for lot release.
- Write and revise work instructions with Engineering and Quality.
To be considered you’ll need:
- a Bachelor’s degree and 3+ years of post -graduate progressive regulated-manufacturing experience or 7+ years of experience in lieu of a degree.
- leadership experience leading hourly teams of 10+ employees.
- working knowledge of ISO 13485, FDA 21 CFR Part 820 and cGMP/Good Documentation Practices.
- experience with NCRs, deviations and CAPA.
- hands-on experience in a controlled environment or cleanroom.
- the ability to work the assigned shift, overtime and weekends as business needs require.
- Ability to stand & walk for 8-12 hours.
- Ability to safely lift up to 50lbs.
- solid company-centric ideology.
- creative problem-solving skills.
- the ability to balance multiple priorities.
- core values of honesty and respect.
- a thirst for learning.
- the desire to be challenged.
You will thrive if you: - Thrive in an autonomous work environment.
- Have a LEAN mindset.
- Are the first person to help.
- Seek out opportunities to bring added value.
Company Benefits & Perks - 401K
- Health Benefits: Medical, Dental, Vision
- Wellness Program
- Life Insurance
- Corporate Sponsored Events
- Skill growth opportunities
- Short Term Disability
- Ability to Advance
- Working with energetic & creative problem solvers
- A mission worthy of your energy and expertise
Applicants for this position must successfully pass a background, drug screening and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
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