Quality Engineer II- Manufacturing Operations
About The Position
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.
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.
- 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.
Nice To Haves
- Bachelor’s degree required in Mechanical Engineering (preferred), Industrial Engineering, Biomedical Engineering, or a related field.
- Knowledge of statistical tools such as ANOVA, capability analysis, and DOE.
- Ability to collaborate effectively with cross-functional teams.
- Experience with NCMRs, CAPAs etc.
- 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 and risk management.
Responsibilities
- Develop, modify, apply, and maintain quality 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 reliability standards and that documentation is compliant with requirements.
- Contribute expertise in 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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
