Quality Engineer I - Exempt

Join our team in North Haven, CT, a vibrant community offering a perfect blend of suburban charm and easy access to urban amenities. As a key member of our design quality team for Sutures & Polymers, you will play a crucial role in maintaining and enhancing our quality and reliability standards. This position requires on-site work at least four days a week.

Responsibilities

• Assess design, manufacturing, process, and supplier changes.
• Review validation and verification documentation and provide feedback.
• Perform Design Failure Modes Effect Analysis (DFMEA).
• Complete risk assessments for proposed changes.
• Perform and support root cause analysis for product complaints.

Additional Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Qualifications

0-2 years of experience required, with skills including but not limited to communication, critical thinking, collaboration, and attention to detail.

Preferred Qualifications

• Experience in the medical device industry or another highly regulated environment.
• Working knowledge of quality systems, risk management, and design controls.
• Strong written and verbal communication skills, including technical writing.
• Experience supporting released medical device products.
• Hands-on experience with DFMEA, risk management files, and design change quality reviews.
• Knowledge of medical device lifecycle requirements, including design, manufacturing, distribution, and obsolescence.
• Experience collaborating with cross-functional teams to resolve quality issues and implement process improvements.
• Familiarity with continuous improvement methodologies and root cause analysis techniques.

Work hours are approximately 9am-5pm EST. The interview process will involve one video call (Microsoft Teams) with behavioral-based questions.