We anticipate the application window for this opening will close on - 29 Sep 2025

 

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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

As a Senior Quality Engineer in manufacturing operations, you’ll play a crucial role in upholding Medtronic’s commitment to quality and patient safety. You’ll partner with production, engineering, and quality teams to support day-to-day operations, foster collaboration, and drive continuous improvement. By proactively addressing production challenges and promoting best practices, you’ll help ensure our products consistently meet Medtronic’s rigorous standards and global regulatory requirements—delivering reliable solutions for patients around the world.

This role is Onsite 5 days a week at the Swinnea Road Manufacturing site, Memphis, TN.

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

• Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance. 

• Monitor and analyze process and product performance data to identify trends, drive root cause analysis, and support continuous improvement. 

• Lead or support nonconformance investigations, risk assessments, and corrective/preventive actions (CAPA) related to manufacturing processes.

• Develop and execute validation of manufacturing processes, equipment, spreadsheets and software (IQ/OQ/PQ). 

• Write, review and/or approve work instructions, inspection plans, process changes, and deviations. 

• Participate in internal and external audits, ensuring readiness and effective response to findings. 

• Champion the use of Lean Six Sigma, statistical tools, FTQ and problem-solving methodologies. 

• Collaborate cross-functionally with operations, engineering, and supply chain to ensure product quality and operational efficiency.

• Perform reviews of Device History Records for product complaints

• May serve as a Subject Matter Expert (SME) for assigned manufacturing processes, equipment or software.

Must Have: Minimum Requirements

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 of experience

Nice to Have

• Validation experience (IQ, OQ, TMV, PQ)

• Software validation experience

• 5+ years of related quality engineering experience

• Previous Quality experience working in medical device or related industry

• Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards

• Experience in DMAIC methodology;  Certified Lean or Six Sigma Green Belt a plus

• Working experience with SAP, inspection software, Excel macros

• Experience interacting with PowerBI

• Strong communication, presentation and collaboration skills

• Comfortable working with international and multi-cultural department & groups in different time zones

• Ability to work well under pressure and maintain positive, enthusiastic attitude

• Ability to work in a fast-paced environment; Eagerness to learn and expand responsibilities & accountability

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