At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Senior Quality Engineer is responsible for managing the site validation program and providing quality engineering support for laboratory operations, special quality improvement projects, and day-to-day quality activities. This role ensures compliance with applicable regulatory requirements, including FDA, ISO, and cGMP standards, while supporting operational excellence and continuous improvement initiatives across the organization. The position serves as a subject matter expert in validation lifecycle management, quality systems, and laboratory support while collaborating cross-functionally with Manufacturing, Engineering, R&D, and Quality teams.

Responsibilities may include the following and other duties may be assigned.

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• Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.
• Develop, review, and approve validation documentation including Validation plans, Protocols (IQ, OQ, PQ), reports and summary documents·
• Support lifecycle management of validated systems, including requalification, change control, and periodic review.
• Provide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).
• Provide quality engineering support to analytical laboratories.
• Assist with method validation/verification and troubleshooting activities. Support laboratory equipment qualification and lifecycle management.· Lead or participate in cross-functional quality improvement projects.· Drive initiatives related to process optimization, validation efficiency, and quality system improvements.
• Support implementation of new technologies, automation, or process changes requiring validation oversight.
• Provide technical expertise during new product introduction (NPI) or process transfer activities.
• Provide day-to-day quality engineering support to operations.
• Support deviation investigations, CAPA development, and root cause analysis. Participate in change control assessments, ensuring proper validation impact evaluation.
• Review and approve technical documentation related to manufacturing and quality systems.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Required Knowledge and Experience: Requires a bachelor’s degree in engineering and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Nice to Have: Preferred Skills

• Strong knowledge of: Validation lifecycle (IQ/OQ/PQ),
• cGMP regulations, Risk management, Root cause analysis methodologies, Quality systems (CAPA, deviations, change control).
• Experience supporting laboratory environments and analytical testing preferred. Strong problem-solving and analytical skills
• Ability to lead cross-functional initiatives
• Effective communication and technical writing skills
• Attention to detail and regulatory compliance mindset
• Ability to manage multiple priorities in a dynamic environment

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

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.

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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.