Operations Quality Engineer II

• ◆Support quality engineering initiatives that improve product quality, manufacturing performance, and quality system effectiveness.
• ◆Partner with manufacturing and engineering teams to establish, maintain, and enhance quality standards and control methods.
• ◆Develop and implement inspection, testing, validation, and monitoring strategies for products and production processes.
• ◆Analyze quality, process, and production data to identify trends, investigate issues, and drive corrective and preventive actions.
• ◆Execute root cause investigations and ensure effective implementation and verification of corrective actions.
• ◆Support regulatory, internal, and external audit readiness through compliant documentation and quality system execution.

• ✓Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience OR Master's degree with 0 years of quality, manufacturing, or engineering experience.

• ✓Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments, including supporting quality systems.
• ✓Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards.
• ✓Experience with process validation, test method validation, and/or equipment qualification activities.
• ✓Experience conducting root cause investigations, implementing corrective and preventive actions (CAPA), and analyzing quality/process data using statistical and problem-solving tools.
• ✓Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies; related certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma preferred.
• ✓Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams.

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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