Quality Engineer - Medical Device - Sturbridge, MA

Quality Engineer

Partner with manufacturing operations to ensure compliance with quality systems, FDA regulations, and medical device industry standards.

Lead investigations involving customer complaints, nonconforming materials, CAPAs, and root cause analysis to drive effective corrective actions.

Support audits, inspections, and regulatory activities while maintaining quality documentation and compliance requirements.

Develop and implement quality improvement initiatives, process validations, risk assessments, and continuous improvement programs.

Collaborate with engineering and manufacturing teams to review design changes, process controls, validations, and new product introductions.

Create and maintain inspection methods, quality plans, testing protocols, and statistical process monitoring systems to ensure product quality.

Work closely with suppliers, customers, and internal stakeholders to resolve quality issues, improve processes, and achieve operational excellence.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Bachelor's degree in Engineering or a related technical field.

2-5 years of Quality Engineering experience within medical device, life sciences, or other regulated manufacturing environments.

Working knowledge of FDA regulations, ISO 13485, ISO 14971, MDSAP, and quality management systems.

Experience with CAPA, complaint investigations, nonconformance management, risk analysis, and validation activities.

Strong understanding of quality engineering tools, statistical analysis, root cause investigations, and continuous improvement methodologies.

Proficiency with Microsoft Office, Minitab, and technical quality documentation.

Excellent communication, problem-solving, and stakeholder management skills with the ability to manage multiple priorities in a fast-paced environment.

Comprehensive medical, dental, vision, and 401(k) benefits starting on day one.

Competitive compensation package with a salary range of $70,000-$95,000.

Generous paid time off program plus 10 paid holidays.

Opportunity to work in a highly regulated industry where quality directly impacts patient outcomes.

Strong career growth potential with exposure to advanced quality systems, regulatory compliance, and continuous improvement initiatives.