Senior Quality Engineer

Medtronic•Toledo, CA

8h•Onsite

About The Position

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.

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.
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.
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.

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.

Responsibilities

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.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).