Quality Engineer II
MedtronicAbout the role
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
In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment, and will provide comprehensive manufacturing quality support throughout the production process.
As a Quality Engineer II, you will:
- Support product and process quality for Class II/III medical devices in a regulated manufacturing environment
- Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis
- Perform risk assessments and support risk management documentation (FMEA, fault tree analysis)
- Provide quality engineering support for design changes, process improvements, and product launches
- Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.)
- Analyze quality trends, monitor metrics, and recommend data-driven actions
- Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity
- Support audits and inspections (internal, supplier, and regulatory bodies)
- Contribute to fostering a culture of inclusion, safety, and continuous learning
Must Have: Minimum Qualifications
- Bachelor’s degree AND minimum of 2 years of relevant experience OR
- Advanced degree with 0 years of experience
Nice to Have: Preferred Qualifications
- 2+ years of relevant quality, manufacturing, or product development experience in a regulated industry (medical device preferred)
- Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems
- Strong analytical, problem-solving, and effective communication skills
- Strong interpersonal and influencing skills
- Experience with CAPA, risk management tools, and statistical analysis
- Lean, Six Sigma, or quality certifications (e.g., ASQ CQE)
- Hands-on knowledge of root cause investigation and validation protocols
- Experience working in an inclusive, cross-functional team setting
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.
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.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account,
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