Haemonetics
Overview
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. About Us
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. Job Summary
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. You’ll set the pace on safety, OEE, schedule attainment, FPY, scrap, and labor productivity—and ensure clean, tight handoffs to the day shift. Key Responsibilities
Safety & Compliance
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).
People Leadership
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.
Production Control
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.
Quality Assurance
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.
Materials & Readiness
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.
Continuous Improvement
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.
Communication & Reporting
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.
General Supervisory Duties
Interview, hire, train, schedule, assign work, evaluate performance, reward/discipline, and resolve grievances in accordance with company policy and law.
Qualifications
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. EEO Policy Statement
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We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. About Us
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. Job Summary
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. You’ll set the pace on safety, OEE, schedule attainment, FPY, scrap, and labor productivity—and ensure clean, tight handoffs to the day shift. Key Responsibilities
Safety & Compliance
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).
People Leadership
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.
Production Control
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.
Quality Assurance
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.
Materials & Readiness
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.
Continuous Improvement
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.
Communication & Reporting
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.
General Supervisory Duties
Interview, hire, train, schedule, assign work, evaluate performance, reward/discipline, and resolve grievances in accordance with company policy and law.
Qualifications
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. EEO Policy Statement
#J-18808-Ljbffr