Senior Quality Engineer

Quality Engineer

Medtronic Santa Ana is looking for an experienced quality engineer to support our manufacturing in Santa Ana, CA. This position is located in Santa Ana, CA (100% on-site role) and reports into Global Manufacturing and Supply Chain Quality organization. Santa Ana site is part of the OC Campus, consisting of Santa Ana, CA (primarily Cardiac Surgery, Structural Heart portfolio) and Irvine, CA (primarily Neurovascular portfolio).

The primary responsibilities for this role includes project management, NPI and day-to-day productions supports with close collaboration with cross-functional supporting teams (engineering, productions, OPEX, microbiology, PMO, facilities, etc.).

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

• Managing and leading NCMRs, CAPAs, and other quality activities that arise.
• Managing and/or supporting projects (sustaining projects and NPI projects).
• Executing Test Method Validations.
• Supporting process validation activities (DQ/IQ/OQ/PQ).
• Leading and/or providing guidance for problem solving using DMAIC methodologies.
• 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.

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 relevant experience.

Nice to Have

• Lean Six Sigma certification
• First Time Quality experience
• Animal tissue processing experience
• ASQ certification such as CQE, CQA

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. 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.

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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