Night Shift Manufacturing Operations Manager

Haemonetics • Clinton, PA

111d

About The Position

At Haemonetics we manufacture critical disposable medical devices and are scaling to meet demand while continuously driving excellent product quality. We’re adding a Night Shift Manufacturing Operations Manager to lead overnight production, safeguarding quality, compliance, and output while keeping people safe.

Requirements

• Bachelor’s degree in industrial engineering, or related field.
• MBA preferred.
• 5+ years leading production teams (medical devices or other regulated manufacturing preferred).
• Working knowledge of GMP, ISO 13485, and FDA 21 CFR 820; CAPA, NCR/NCE, change control familiarity.
• Proven results improving OEE, FPY, scrap, and schedule attainment.
• Strong floor presence, communication, and decision-making—especially under limited off-hour support.
• Comfortable with nightshift work and schedule flexibility as business needs evolve.

Responsibilities

• Own end-to-end night-shift operations.
• Lead supervisors, group leaders, and hourly teams to hit plan, protect quality, maintain compliance (21 CFR 820/ISO 13485/GMP/GDP), and drive continuous improvement.
• Champion a zero-injury culture; enforce LOTO, PPE, and cleanroom/gowning standards.
• Ensure strict adherence to FDA, ISO 13485, GMP, and Good Documentation Practices; audit batch records/travelers for completeness and accuracy.
• Lead incident investigations and near-miss reviews; implement corrective and preventive actions (CAPA).
• Lead and develop supervisors, group leaders, and operators: staffing, onboarding, coaching, performance management, and recognition.
• Set clear expectations and standard work; hold the line on accountability and attendance.
• Maintain morale and discipline on the night shift; resolve conflicts and escalate appropriately.
• Own the shift schedule to meet plan; manage changeovers, start-ups, and shutdowns.
• Monitor line health in real time (Overall Equipment Effectiveness, cycle times, yields); remove bottlenecks fast.
• Coordinate with Maintenance and Engineering for break-fix, PM compliance, and downtime reduction; manage call-in/escalation.
• Ensure products meet or exceed specifications; oversee in-process checks, line clearance, and lot control.
• Drive first-pass yield and scrap reduction; contain defects immediately with documented NCE/NCR and disposition.
• Partner with Quality on deviations, investigations, and change control.
• Align with Planning/Materials on kitting, WIP flow, and inventory accuracy; prevent line starves/stops.
• Verify tooling/fixtures availability and readiness; manage consumables and 5S standards.
• Identify waste and variability; lead Kaizen/PDCA to improve throughput, cost, and stability.
• Promote and lead quick, easy Kaizens, 5S, and GEMBA walks.
• Standardize best practices across crews; update work instructions and training as processes evolve.
• Run crisp tier meetings; communicate priorities, issues, and countermeasures.
• Deliver nightly KPIs (OEE, FPY, scrap, attainment, downtime, safety) and next-shift risks.
• Execute disciplined shift handoff to days/evenings with clear actions and owners.
• Interview, hire, train, schedule, assign work, evaluate performance, reward/discipline, and resolve grievances in accordance with company policy and law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees