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Job Details
About Us
At Haemonetics we manufacture critical disposable medical devices and are scaling to meet demand while continuously driving excellent product quality. Were 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. Youll set the pace on safety OEE schedule attainment FPY scrap and labor productivityand 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
- Bachelors 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-makingespecially under limited off-hour support.
- Comfortable with nightshift work and schedule flexibility as business needs evolve.
EEO Policy Statement
Required Experience:
Manager