Manufacturing Supervisor - Lean, Quality & Compliance

Hologic, Inc.; Marlborough (MA); On-site; USD 77,000 - 128,000; Full time

Job summary

Hologic, Inc. is seeking a Manufacturing Supervisor to lead day-to-day operations, ensuring safety, quality, delivery, and productivity targets are met.

The role provides direct leadership to production staff and collaborates with Engineering, Quality, Regulatory Affairs, EH&S, and Materials teams. Responsibilities include coaching and developing personnel, driving Lean, 6S, and continuous improvement, maintaining documentation, audits, and compliance with FDA, ISO, and GMP standards, and

Qualifications

• Associate's degree in a technical discipline or equivalent combination of education and experience required.
• Minimum of 3 years of leadership or supervisory experience in a manufacturing environment.
• Minimum of 5 years of manufacturing experience with a strong electrical and/or mechanical background.
• Experience working in FDA-regulated and ISO-certified environments required.
• Experience working in a cleanroom manufacturing environment preferred.
• Results-oriented with a strong continuous improvement mindset.
• Strong leadership, coaching, mentoring, and employee development skills.
• Excellent interpersonal, conflict resolution, and team-building capabilities.
• Strong analytical, organizational, and problem-solving skills.
• Effective written and verbal communication skills.
• Knowledge of Lean Manufacturing principles and Continuous Improvement methodologies.
• Experience with GMPs, QSRs, MRP systems, and manufacturing best practices.
• Strong documentation, recordkeeping, and auditing skills with a high level of attention to detail.
• Proficient in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Experience with Oracle and Agile systems preferred.
• Familiarity with mechanical assembly, manufacturing equipment, testing, and repair processes.

Responsibilities

• Supervise daily manufacturing operations to ensure production schedules, quality requirements, and business objectives are achieved.
• Lead, coach, and develop manufacturing personnel to drive engagement, performance, and accountability.
• Monitor employee performance and ensure adherence to established procedures, quality standards, and production goals.
• Manage staffing levels, scheduling, timekeeping, attendance, and vacation requests to support operational requirements.
• Partner with Engineering, Manufacturing Engineering, Quality, Regulatory Affairs, EH&S, and Materials teams to support manufacturing activities and resolve operational issues.
• Drive Lean Manufacturing, 6S, and Continuous Improvement initiatives to improve efficiency, reduce waste, and optimize performance.
• Identify, recommend, and implement process improvements that enhance productivity, quality, and safety.
• Conduct departmental audits and inspections to ensure compliance with regulatory requirements and company procedures.
• Support process validations, investigations, testing activities, and implementation of manufacturing changes as required.
• Ensure manufacturing methods, processes, and documentation comply with applicable quality and regulatory requirements.
• Review production performance and quality metrics and communicate results to management.
• Coordinate equipment and supply purchases within approved budgets.
• Maintain accurate documentation, including review of Device History Records (DHRs) and associated manufacturing records.
• Conduct performance evaluations and provide ongoing coaching, development, and corrective action when necessary.
• Foster a culture focused on safety, quality, teamwork, and continuous improvement.
• Maintain a clean, organized, and safe work environment.

Skills

Leadership

Coaching

Team building

Problem solving

Communication

Lean Manufacturing

Documentation

Microsoft Office

Regulatory knowledge

GMP/QSR

Education

Associate's degree in a technical discipline

Tools

Oracle

Agile

MRP systems

Excel

PowerPoint

Word

Job description

Hologic, Inc. is seeking a Manufacturing Supervisor to lead day-to-day operations, ensuring safety, quality, delivery, and productivity targets are met.

The role provides direct leadership to production staff and collaborates with Engineering, Quality, Regulatory Affairs, EH&S, and Materials teams. Responsibilities include coaching and developing personnel, driving Lean, 6S, and continuous improvement, maintaining documentation, audits, and compliance with FDA, ISO, and GMP standards, and