Head of Cleanroom Operations & Lean Excellence

Flow Control Group

Northampton (MA)

On-site

USD 110,000 - 140,000

Full time

3 days ago

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Job summary

In this role you will partner with Quality, Sales, and Engineering to execute reliable production schedules, reduce lead times, and improve throughput while maintaining cost discipline across North American operations.

Qualifications

Bachelor's degree in Engineering, Operations, Supply Chain, Manufacturing, Life Sciences, or a related field preferred.
7–10+ years of progressive manufacturing, operations, supply chain, or plant leadership experience.
Demonstrated leadership of assembly manufacturing with responsibility for production performance, scheduling, capacity, labor, and delivery.
Strong supply chain experience, including materials planning, purchasing, inventory management, lot control, expiration management, and production planning.
Demonstrated experience using ERP systems for production planning, material requirements, inventory management, costing, and operational reporting.
Practical experience with Lean manufacturing, continuous improvement, standard work, visual management, and/or Tiered Daily Management.
Experience in a regulated, quality-sensitive, cleanroom, medical, pharmaceutical, biotech, life sciences, or similar manufacturing environment strongly preferred.
Working knowledge of ISO 13485, GMP principles, cleanroom practices, or comparable quality systems preferred.
Strong analytical, problem-solving, communication, and people-development skills, with a hands-on leadership style and the ability to use data to drive accountability and decisions.

Responsibilities

Lead cleanroom and hose assembly operations, including production planning, scheduling, capacity, labor utilization, workflow, productivity, and on-time delivery.
Translate customer demand and business priorities into realistic production plans, balancing capacity, materials, labor, quality, and delivery commitments.
Maintain a visible presence on the production floor; identify constraints, resolve issues, and drive accountability for safety, quality, delivery, productivity, and cost.
Ensure operating processes, documentation, traceability, and cleanroom practices support the site's ISO 13485 Quality Management System and customer requirements.
Lead supply chain activities covering purchasing, material availability, inventory planning, and coordination with production.
Maintain accurate control of raw materials and finished goods, including lot traceability, expiration dates, inventory accuracy, and material disposition.
Use the ERP system as a core operating tool for production planning, material requirements, scheduling, inventory planning, costing, and performance reporting.
Improve the connection between demand, purchasing, inventory, production capacity, and customer delivery while balancing service, working capital, and expiration risk.
Establish meaningful KPIs for safety, quality, delivery, productivity, inventory, and cost; use them to identify problems, upscale issues, and drive structured root‑cause problem solving.
Lead measurable improvements in throughput, lead time, labor efficiency, inventory, quality, and customer delivery.
Partner closely with Quality to resolve process issues, nonconformances, and corrective actions while maintaining production continuity and compliance with ISO 13485 requirements.
Work effectively with Sales, Customer Service, Engineering, and Quality to establish realistic commitments and reliable execution.
Build a culture of ownership, teamwork, safety, quality, continuous improvement, and customer focus while developing frontline leadership capability and operational talent.