Senior Quality Engineer
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
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
As a Senior Quality Engineer, you will be responsible for supporting manufacturing operations at the Irvine Toledo site by leading activities such as NCMRs, DHR review, CAPA execution, Inspection Optimization, and NPI support. This role ensures quality compliance and drives continuous improvement across manufacturing processes, while also leading projects to design, develop, and implement quality improvements and process changes.
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Collaborating with multiple OUs and Supplier Quality to provide inspection process support
- Owning and Driving NCMR/CAPA resolution in impacted supported areas
- Using lean six sigma principles to streamline manufacturing processes and enhance efficiency.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Provide guidance and support in project management, problem-solving, and professional development.
Must Have: Minimum Requirements
Requires a Baccalaureate degree 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 Haves:
- Experience supporting Manufacturing Line Support (Operations Quality)
- Experience in project management
- Knowledge developing and implementing Test Methods, as well as TMVs
- Lean Six Sigma/DRM Knowledge
- Process improvement mindset
- knowledge of ISO 13485 and QSR 21 CFR 820 requirements.
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.
<Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s