Senior Quality Engineer at COV Covidien LP — North Haven, CT

A Day in the Life

This position will support the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group located in North Haven, CT. We are seeking a Senior Quality Engineer to join our team in North Haven, CT. A key requirement of this role is deep expertise in process validation across the full validation lifecycle, with the ability to support complex manufacturing processes in highly regulated environments. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role is 100% onsite at our North Haven, CT manufacturing site.

• Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• 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 the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Have: Minimum Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.

Nice to Have

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred.
• Strong expertise in process validation across the full validation lifecycle, supporting complex manufacturing processes in regulated environments.
• Proven experience leading root cause investigations, CAPA development, and management of nonconforming material (NCMR) activities.
• Proficiency in statistical analysis and tools (e.g., Minitab) to support data-driven, risk-based decision making and continuous improvement.
• Demonstrated ability to mentor engineers and collaborate effectively across cross-functional teams.
• Experience in FDA-regulated manufacturing (medical device and/or pharmaceutical) with working knowledge of CFR requirements, engineering drawings, and end-to-end manufacturing processes including machining, chemical processing, packaging, and sterilization.

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00