Quality Engineer II

Medtronic • Toledo, OH

1d • $79,200 - $118,800 • Onsite

About The Position

Medtronic’s Global Operations and Supply Chain organization is seeking a Quality Engineer II for its Quality Operations team in Irvine, California. The role supports key programs within the Quality Management System and day-to-day quality and compliance activities in the development and manufacture of medical devices. It calls for a collaborative, hands-on professional with strong analytical skills, a foundation in quality engineering principles, and the ability to manage multiple priorities. The position is onsite five days per week.

Requirements

• Baccalaureate degree and at least 2 years of relevant quality experience, or a master's degree and at least 0 years of relevant experience.
• For a baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• For roles below Principal level, candidates must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is not offered for this role.

Nice To Haves

• Bachelor’s degree 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 and CAPAs.
• 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.
• Collaborate with engineering and manufacturing functions to establish quality standards.
• Develop and implement methods and procedures to inspect, test, and evaluate product and production-equipment precision and accuracy.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests and perform statistical analysis to assess the cost of and determine responsibility for products or materials that fail to meet standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and that documentation complies with requirements.
• May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, or research and development as applied to product or process quality.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and Simple Steps global well-being program.
• For all regular employees: incentive plans; 401(k) plan with 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); and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level