Senior Quality Engineer

Senior Quality Engineer

Location:

North Haven, CT. This role supports the Surgical Sutures’ Manufacturing business within Medtronic’s Surgical Innovations group. You will collaborate cross‑functionally to ensure the highest standards of quality and compliance in medical device manufacturing processes.

• Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished 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.

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• 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.

• 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.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles:
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise‑wide workforce planning approach, U.S. work authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Salary ranges for U.S.…