Quality Engineer - CAPA, ISO 9001

Quality Engineer

Based in Billerica, MA, we are an industry leader manufacturing highly engineered electro-mechanical products for customers operating in regulated and technology-driven industries.

We're seeking a Quality Engineer to lead product quality initiatives, resolve customer quality issues, drive continuous improvement efforts, and support manufacturing operations through strong problem-solving and quality engineering practices. This role will work closely with Manufacturing, Engineering, Service, Supply Chain, and Quality teams to improve product reliability, reduce defects, and ensure customer satisfaction.

Role and Responsibilities

• Serve as the primary quality lead for product quality, reliability, and customer quality concerns
• Establish and implement processes for resolving customer quality issues and product non-conformances
• Define and improve inspection requirements, quality standards, sampling plans, and shop-floor quality processes
• Partner with Manufacturing to identify failure modes and implement corrective actions
• Drive CAPA activities and ensure timely resolution of quality findings
• Lead root cause investigations utilizing 8D, 5-Why, Fishbone Diagrams, FMEA, and related methodologies
• Support incoming, in-process, and final inspection activities
• Analyze quality data and communicate trends, findings, and recommendations to leadership
• Participate in product failure analysis and reliability improvement initiatives
• Conduct audits of manufacturing processes and quality systems
• Support new product development and prototype activities to ensure quality requirements are met
• Drive supplier quality improvements and support corrective action efforts with key suppliers
• Mentor team members on quality tools, statistical methods, and problem-solving techniques
• Promote Lean Manufacturing, Six Sigma, and continuous improvement initiatives throughout the organization
• Support domestic and international customers as required and travel up to 10%

Qualifications

• Bachelor's degree in Engineering or related technical discipline
• 3+ years of Quality Engineering experience in a manufacturing environment
• Experience supporting machining, welding, brazing, assembly, or electro-mechanical manufacturing processes
• Experience operating within an ISO 9001 quality environment; AS9100 experience is a strong plus
• Experience leading root cause investigations, CAPA activities, and corrective action implementation
• Strong understanding of GD&T, SPC, FMEA, 8D, 5-Why, Six Sigma, Lean Manufacturing, and quality improvement methodologies
• Experience utilizing Minitab and statistical analysis tools
• Understanding of capability studies, Gage R&R, control charts, and process validation techniques
• Experience working directly with suppliers, manufacturing teams, engineering groups, and customers
• Experience with pumps, plumbing systems, brazing, refrigeration systems, or electro-mechanical products is desirable
• Strong communication, project management, troubleshooting, and analytical skills
• Ability to work independently while managing multiple projects and priorities