Quality Engineer III - Medical Device - Danbury, CT

• Lead quality engineering initiatives across new product development, manufacturing, and continuous improvement projects.
• Drive risk management, root cause investigations, CAPA activities, and process improvement efforts.
• Develop and execute equipment, process, and product validations while ensuring regulatory compliance.
• Create and maintain quality plans, procedures, technical documentation, and validation reports.
• Apply statistical analysis, SPC, and data-driven methodologies to enhance product and process performance.
• Partner with customers, suppliers, and cross-functional teams to resolve quality issues and improve outcomes.
• Ensure compliance with ISO 13485, FDA regulations, and internal quality system requirements.
• Provide technical leadership, mentorship, and quality expertise to support organizational growth and 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.

Lead quality initiatives for cutting-edge medical manufacturing programsHigh-impact role with growth, innovation, and cross-functional leadership

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Minimum of 2 years of Quality Engineering experience within a medical device, regulated manufacturing, or similar engineering environment.
• Working knowledge of ISO 13485 and FDA 21 CFR 820 quality and regulatory requirements.
• Experience creating and maintaining quality documentation, validation protocols, and technical reports.
• Strong problem-solving, technical writing, and communication skills.
• Experience with statistical analysis tools, SPC methodologies, and software such as Minitab.
• Ability to collaborate effectively with customers, suppliers, and cross-functional teams.
• Experience supporting supplier audits, qualification activities, and quality system improvements.
• CQE certification and/or Six Sigma Green Belt preferred.
• Strong organizational skills with the ability to manage multiple projects independently.

Our client is an innovative, rapidly expanding engineering and manufacturing company that supports highly regulated products used in critical applications. Known for investing in advanced technologies and continuous improvement, they offer an employee-focused environment where technical expertise and innovation are highly valued.

• Join a growing organization investing heavily in technology and innovation with the medical device environment.
• Take ownership of high-visibility quality and continuous improvement projects.
• Work directly with customers, engineering teams, and senior technical leaders.
• Gain exposure to advanced manufacturing and regulated product development environments.
• Enjoy strong opportunities for career growth, technical development, and leadership progression.
• Comprehensive benefits package.