Sustaining Quality Manager - Medical Device Manufacturing
Orion Global Talent - Vermont, United States
Hiring: Sustaining Quality Manager - Medical Device Manufacturing Company: Orion Global Talent Location: Vermont, United States Job Posted Time: 2026-09-10 13:39:34 Target Skills & Keywords : Assembly, Program Management, R, Regulatory Compliance, Root Cause Analysis, Six Sigma About the job Experience: •7+ years of Quality Engineering or Quality Management experience in regulated manufacturing •3+ years of leadership experience Required Skills: •The Sustaining Quality Manager will lead quality engineering activities supporting ongoing production, customer satisfaction, CAPA, nonconformance reduction, process validation, supplier quality, and regulatory compliance. •Working closely with Operations, Manufacturing Engineering, Program Management, Regulatory Affairs, suppliers, and customers, you will ensure products and processes consistently meet quality, regulatory, and customer requirements. •Lead and mentor •Sustaining Quality Engineers and Quality Technicians •Ensure compliance with ISO 13485, FDA, GMP •Manage quality performance for existing production programs •CAPA, nonconformance, customer complaint, and root cause investigations •Yield, scrap, PPM, COPQ, process capability, and customer quality metrics Qualifications: •Demonstrated success leading root cause analysis and continuous improvement initiatives •Strong communication, organizational, and cross-functional leadership skills •ASQ Certified Quality Manager (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Lean Six Sigma Green Belt or Black Belt. •Beyond the technical challenge, this is an opportunity to join an organization known for its strong culture, high employee retention, collaborative leadership, and commitment to work-life balance •If you are an experienced Quality Manager or Senior Quality Engineer ready to take on a broader leadership role in a regulated manufacturing environment, we would like to hear from you. •This position is at our client's Vermont manufacturing facility. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!