Senior Quality Engineer

Medtronic•Salt Lake City, UT

2d•$98,400 - $147,600•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 partners with engineering and manufacturing teams to establish compliant, effective, and sustainable manufacturing processes and to advance product quality, process reliability, and regulatory compliance in a highly regulated medical device environment. The Operations Quality team works with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations. This position is based at the West Valley, Utah manufacturing facility and requires onsite work five days per week.

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 that satisfies 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 in 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.
Two or more years of experience executing process validation activities across the full validation lifecycle.

Responsibilities

Lead process validation 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.
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.
Short-term incentive through the Medtronic Incentive Plan (MIP).
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 and tuition assistance/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.
Incentive plans for all regular employees.
401(k) plan with employer contribution and match for all regular employees.
Short-term disability, paid time off, and paid holidays for all regular employees.
Employee Stock Purchase Plan and Employee Assistance Program for all regular employees.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums.
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.