More jobs:
Quality Engineer II- Manufacturing Operations
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-06-19
Listing for:
Medtronic
Full Time
position Listed on 2026-06-19
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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.
The Medtronic Global Operations and Supply Chain (GOSC) organization is seeking a Quality Engineer II to join our growing Quality Operations team in Irvine, California. In this role, you will support key programs within our Quality Management System and help drive day-to-day quality and compliance activities in the development and manufacturing of innovative medical devices.
We are looking for a collaborative, hands-on professional who is motivated to make an impact in a dynamic environment. The ideal candidate brings strong analytical skills, a solid foundation in quality engineering principles, and the ability to manage multiple priorities effectively while continuing to grow professionally.
Please note that this is a fully onsite role based in Irvine, California.
** Responsibilities may include the following.*
* ** Additional*
* ** duties may be assigned as needed.*
* + Develop,modify, apply, andmaintainquality standards and protocols for processing materials into partially finished or finished products.
+ 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.
+ Design or specify inspection and testing methods and equipment, conduct quality assurance testing, and perform statistical analyses to evaluate product or material nonconformance and support resolution.
+ Ensures that corrective measures meet acceptable reliabilitystandardsand that documentation is compliant with requirements.
+ Contributeexpertisein areas such as design quality, incoming materials, production control, product evaluation and reliability, inventory control, and research and development as they relate to product or process quality.
** Must Have:*
* ** Minimum*
* ** Requirements*
* Requires a Baccalaureate degree and minimum of 2 years of relevant Quality experience OR Master's degree with a minimum of 0 years relevant experience.
** Nice to Have*
* + Bachelor's degreerequiredin Mechanical Engineering (preferred), Industrial Engineering, Biomedical Engineering, ora related field.
+ Knowledge of statistical tools such as ANOVA, capability analysis, and DOE.
+ Ability to collaborate effectively with cross-functional teams.
+
Experience with NCMRs,CAPAsetc.
+ DRM or Design for Six Sigma certification.
+
Experience with process validation.
+
Experience with test method validation.
+ Experience in medical device manufacturing and familiarity with applicable regulations and standards.
+
Experience with FMEA andrisk management
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…
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