Plant General Manager, Regulated Manufacturing

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.