Quality Engineer II
Listed on 2026-10-22
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
We anticipate the application window for this opening will close on - 27 Oct
2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life The Quality Engineering function partners across manufacturing, operations, and quality teams to improve product and process performance through risk identification, prevention, and continuous improvement. This team focuses on strengthening quality systems, advancing First Time Quality (FTQ) practices, reducing manufacturing and process variation, and supporting compliant, scalable operations that prioritize patient safety and product quality. This Hybrid Flex position is based at Rice Creek - West and requires onsite presence four days per week.
25% travel is required. As a Quality Engineer II, you will drive initiatives that improve manufacturing and business process quality by reducing risk, improving process stability, and embedding First Time Quality principles across operations. This role partners with cross‑functional teams to implement sustainable quality improvements, strengthen compliance, and support projects that enhance operational performance and product quality.
- 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.
- 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.
- 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.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8C.F.R. §214.2(h)(4)(iii)(A) is required.
Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of…
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