Operations / Production Manager

Position Summary The Operations / Production Manager is responsible for building and leading a high-performing manufacturing team in a regulated medical device cleanroom environment. This role drives operational excellence across safety, quality, delivery, and cost while serving as a champion of Lean Manufacturing and Continuous Improvement. This leader will partner cross-functionally with Quality, Engineering, and Supply Chain to ensure compliant, efficient, and scalable production processes aligned with Quality System Regulations (QSR) and environmental, health, and safety (EHS) standards. Key Responsibilities Lead, develop, and scale a best-in-class manufacturing team supporting all company-produced medical devices Foster a culture of accountability, engagement, and continuous improvement within a cleanroom production environment Establish clear performance goals, drive cross-training initiatives, and build bench strength across the production team Champion Lean Manufacturing principles to improve throughput, reduce waste, and enhance product quality Drive process improvement initiatives using structured methodologies, including process mapping, root cause analysis, and waste reduction Partner with Quality to ensure compliance with FDA regulations, ISO standards, and internal Quality Management Systems Collaborate with Supply Chain to develop and execute production schedules, capacity planning, and inventory strategies Optimize manufacturing workflows, line balancing, and material flow within controlled environments Define, track, and respond to key operational KPIs (e.g., yield, throughput, on-time delivery, scrap) Support process validation, documentation, and continuous improvement initiatives Ensure adherence to all environmental, health, and safety (EHS) policies and procedures Qualifications Bachelor's degree required (Engineering, Operations, or related field preferred) 5+ years of leadership experience in production or operations within a medical device manufacturing environment Direct experience working in cleanroom or controlled production environments Strong foundation in Lean Manufacturing principles with hands-on application Experience with Six Sigma methodologies (Green Belt or higher preferred) Demonstrated expertise in process improvement , including process mapping, workflow optimization, and problem-solving tools Comfortable operating in a fast-paced, hands-on production environment with a strong floor presence Strong knowledge of FDA regulations, ISO 13485, and Quality System requirements Proven ability to lead teams, drive accountability, and influence cross-functional partners Highly organized with strong attention to detail and analytical problem-solving skills Proficient in Microsoft Office (Excel, Word, PowerPoint) Experience with HRIS systems such as Paylocity or Ease is a plus Email Resume scott.slater@gogpac.com Call 515-461-1578