Quality Engineer II

Medtronic•Fridley, MN
•Hybrid

About The Position

The Quality Engineer II drives initiatives to improve manufacturing and business process quality by reducing risk, improving process stability, and embedding First Time Quality (FTQ) principles across operations. The role partners with cross-functional teams to implement sustainable quality improvements, strengthen compliance, and support projects that enhance operational performance and product quality. The Quality Engineering function works across manufacturing, operations, and quality teams on risk identification, prevention, continuous improvement, quality systems, FTQ practices, and reducing manufacturing and process variation to support patient safety and product quality. This Hybrid Flex position is based at Rice Creek - West and requires onsite presence four days per week. The role requires 25% travel.

Requirements

  • Bachelor's degree and 2+ years of relevant experience, or a Master's degree.
  • Experience supporting quality improvement initiatives within a regulated industry.
  • Experience analyzing process performance and using data to drive quality improvements.
  • Experience working with quality systems, compliance requirements, or continuous improvement programs.
  • 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

  • Experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing environments.
  • Experience with First Time Quality (FTQ), Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
  • Experience leading cross-functional quality or process improvement projects.
  • Knowledge of manufacturing risk management, process validation, or quality engineering tools.
  • Experience establishing and monitoring quality metrics and performance indicators.

Responsibilities

  • Lead projects that reduce factory escape risks across internal and external manufacturing sites.
  • Drive elimination of rework and reprocessing activities to improve process efficiency and value stream stability.
  • Define, implement, and enhance First Time Quality (FTQ) programs, metrics, and governance processes.
  • Partner with manufacturing and engineering teams to embed quality controls into new production lines and equipment.
  • Implement First Time Quality principles within transactional and non-manufacturing processes.
  • Support development and maintenance of a compliant, scalable Quality Management System.
  • Interpret regulatory requirements, agency guidelines, and internal policies to ensure compliance.
  • Manage project activities, including planning, risk identification, issue resolution, resource coordination, and communication of project status.

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.
  • 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.
  • Short-term incentive through the Medtronic Incentive Plan (MIP).
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