Sustaining Quality Manager - Medical Device Manufacturing

The Opportunity: 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.

Key Responsibilities: Lead and mentor Sustaining Quality Engineers and Quality Technicians Ensure compliance with ISO 13485, FDA, GMP, QMS, and customer requirements Manage quality performance for existing production programs Lead CAPA, nonconformance, customer complaint, and root cause investigations Apply problem-solving methodologies including 5 Why, Fishbone, and DMAICMonitor and improve yield, scrap, PPM, COPQ, process capability, and customer quality metrics Lead continuous improvement initiatives to reduce defects and improve process stability Support IQ/OQ/PQ process validation and revalidation Review engineering changes, process modifications, risk assessments, and change controls Serve as a key quality contact for customers and lead quality reviews and issue resolution Support internal, customer, supplier, and regulatory audits Partner with Supplier Quality and Purchasing on supplier performance and corrective actions Develop and present quality KPIs and performance metrics to site leadership Promote a strong culture of quality ownership and continuous improvement

What We're Looking For: Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences, or related discipline 7+ years of Quality Engineering or Quality Management experience in regulated manufacturing 3+ years of leadership experience Strong knowledge of ISO 13485, FDA requirements, CAPA, QMS, SPC, FMEA, MSA/Gage R&R, and process validation Experience with medical devices, injection molding, assembly, or highly regulated manufacturingstrongly preferred Demonstrated success leading root cause analysis and continuous improvement initiatives Strong communication, organizational, and cross-functional leadership skills Preferred Certifications ASQ Certified Quality Manager (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Lean Six Sigma Green Belt or Black Belt. Why Consider This Opportunity? 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.