Production Supervisor Jobs

About The Position

Requirements

• 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.

Nice To Haves

• Thrive in an autonomous work environment.
• Have a LEAN mindset.
• Are the first person to help.
• Seek out opportunities to bring added value.

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.

Benefits

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance