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.ResponsibilitiesAssess 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 ResponsibilitiesDevelop, 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.Qualifications0-2 years of experience required, with skills including but not limited to communication, critical thinking, collaboration, and attention to detail.Preferred QualificationsExperience 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.