Quality Engineer II

This Hybrid Flex position is based at Rice Creek – West and requires onsite presence four days per week with 25% travel. The Quality Engineering function partners across manufacturing, operations, and quality teams to improve product and process performance through risk identification, prevention, and continuous improvement, focusing on strengthening quality systems, advancing First Time Quality (FTQ) practices, reducing variation, and supporting compliant, scalable operations that prioritize patient safety and product quality.

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.

Requirements

Must Have (Minimum Requirements)

• Bachelor's degree and 2+ years of relevant experience OR 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 Have

• 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.

Physical Requirements

For office roles: while performing the duties of this job, the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Authorization

U.S. work authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for Principal‑level roles and above. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Salary range (U.S., excluding Puerto Rico and specific California locations): $79,200 – $118,800 (USD). This position is eligible for the Medtronic Incentive Plan (MIP). The offered rate complies with federal and local regulations and may vary based on experience, certification/education, market conditions, and location.

Benefits for regular employees working 20+ 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/reimbursement
• Simple Steps (global well‑being program)

Benefits for all regular employees

• 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)

Temporary employees are eligible for paid sick time (as required under applicable state law) and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico.