Senior Quality Engineer - North Haven, CT

• ◆Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
• ◆Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
• ◆Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
• ◆Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
• ◆Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
• ◆Support qualification and validation of manufacturing equipment, processes, and test methods.
• ◆Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
• ◆Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.

• ✓Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
• ✓2+ years of experience executing process validation activities across the full validation lifecycle.

• ✓Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.
• ✓Experience leading process validation activities for complex manufacturing processes in regulated environments.
• ✓Experience with FDA-regulated medical device or pharmaceutical manufacturing.
• ✓Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
• ✓Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
• ✓ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the

of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job

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

and skills of this position.

The physical demands described within the

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

that may be specific to each role.

U.S. Work Authorization & Sponsorship

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.

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