Quality Engineer II

Medtronic•Irvine, CA

1d•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 programs within the Quality Management System and day-to-day quality and compliance activities related to developing and manufacturing medical devices. It calls for a collaborative, hands-on professional with analytical skills, a foundation in quality engineering, and the ability to manage multiple priorities. The position is onsite five days per week to support professional growth and cross-functional collaboration. The Quality Engineer develops and maintains quality standards and protocols; works with engineering and manufacturing to establish quality standards; and creates inspection, testing, and evaluation methods. The role also conducts quality assurance testing and statistical analysis, and ensures corrective actions meet reliability standards and documentation requirements. Work may focus on design, incoming materials, production control, product evaluation and reliability, inventory control, or research and development as they relate to product or process quality.

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 baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Roles below Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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, CAPAs, and similar quality processes.
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 ensure quality standards are in place.
Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
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 required standards and specifications.
Ensure corrective measures meet acceptable reliability standards and that documentation complies with requirements.
Support key Quality Management System programs and day-to-day quality and compliance activities in medical device development and manufacturing.
May specialize in design, incoming material, production control, product evaluation and reliability, inventory control, or research and development as they apply to product or process quality.

Benefits

Competitive salary and flexible benefits package.
Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account and Healthcare Flexible Spending Account for eligible regular employees working 20 or more hours per week.
Life insurance and long-term disability leave for eligible regular employees working 20 or more hours per week.
Dependent daycare spending account for eligible regular employees working 20 or more hours per week.
Tuition assistance or reimbursement for eligible regular employees working 20 or more hours per week.
Simple Steps global well-being program for eligible regular employees working 20 or more hours per week.
Medtronic Incentive Plan short-term incentive.
Incentive plans for regular employees.
401(k) plan with employer contribution and match for regular employees.
Short-term disability for regular employees.
Paid time off and paid holidays for regular employees.
Employee Stock Purchase Plan for regular employees.
Employee Assistance Program for regular employees.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums, for regular employees.
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.