Plant General Manager, Regulated Manufacturing

Job Description

Job Description

Build what matters. Lead what’s next.

As Plant General Manager, you will turn strategy into execution—accelerating throughput, safeguarding quality, and delivering for customers in a regulated environment. You’ll integrate Facilities, MFG Ops, Post Machining Ops, and Quality Ops into a cohesive, high‑performance operation and be accountable for all manufacturing and acceptance activities on site.

• Own plant supply, production, and customer service results for the site.
• Set the plant’s strategic direction to achieve manufacturing goals and the company’s strategic deployment objectives.
• Shape and manage short‑ and long‑term business plans: annual operating plan, capital projects, operating costs, and personnel/headcount utilization to sustain manufacturing efforts.

• Plan, direct, and coordinate production and delivery to meet every customer commitment.
• Use ERP and corporate financial systems to report operational and financial performance.
• Assist with budget development; monitor and control direct/indirect costs against plan.
• Oversee material flow through production to meet monthly schedules; deploy labor to keep work moving.
• Stand up and track quality and cost improvement programs; manage process improvement initiatives.
• Apply Lean daily management to drive sustainable performance.
• Develop, implement, and update operating policies and procedures.
• Report site activities and metrics; provide periodic updates and special status reports to leadership and customers.
• Create communication rhythms so employees are engaged, informed, and aligned with business priorities.
• Adhere to the TOMZ Quality Management System and perform other duties as assigned.

• Consistent achievement of EH&S objectives, on‑time delivery, quality targets, cost management goals, and sound inventory control.
• Measurable cost reductions on existing products through continuous improvement.
• Stable, predictable flow enabled by Lean and Six Sigma practices.

• Demonstrated leadership in plant operations, including production planning, quality control, cost reduction, supply chain, and manufacturing engineering.
• Proven Lean manufacturing experience with business‑driven application.
• Mandatory ERP experience and strong MS Office skills.
• Ability to lead, plan, and manage a diverse manufacturing business; decisive with minimal direction.
• Experience within Medical Device or other regulated manufacturing.
• Strong leadership, communication, and change management skills; excellent oral and written communication.
• Knowledge and experience with Lean and Six Sigma methods.

• Bachelor’s or Master’s degree in Business, Engineering, or related field.
• 7–10 years of manufacturing and operations experience with Plant/Senior Management leadership.

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds; team lift/mechanical assist required over 50 pounds.
• Ability to sit or stand for long periods.
• Exposure may include oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp‑edged materials; PPE such as safety glasses, dust masks, ear plugs, cut‑resistant or chemical‑resistant gloves, and engineering controls may be required.