Senior Quality Engineer - 2nd shift

Medtronic•West Valley, UT

3d•Onsite

About The Position

The Senior Quality Engineer provides quality engineering support for manufacturing operations, with a primary focus on process validation and quality system execution. The role works closely with manufacturing, engineering, and technical teams to ensure compliant, effective, and sustainable manufacturing processes and to advance product quality, process reliability, and regulatory compliance in a highly regulated medical device environment. The position is based onsite at Medtronic’s manufacturing facility in West Valley City, Utah, and works Monday through Thursday from 3:30 p.m. to 2:00 a.m. (second shift).

Requirements

Bachelor’s degree in Engineering, Science, or a technical field and 4 or more years of engineering and/or quality experience; or a master’s degree in Engineering, Science, or a technical field and 2 or more years of engineering and/or quality experience; or a PhD.
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.

Nice To Haves

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related engineering discipline; an advanced degree is preferred.
Experience leading process validation activities for complex manufacturing processes in regulated environments.
Experience with FDA-regulated medical device or pharmaceutical manufacturing.
Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
2 or more years of experience executing process validation activities across the full validation lifecycle.

Responsibilities

Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
Support qualification and validation of manufacturing equipment, processes, and test methods.
Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.

Benefits

Competitive salary and flexible benefits package.
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, including the Medtronic Incentive Plan short-term incentive.
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.
Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.