Operations Quality Engineer II

We anticipate the application window for this opening will close on - 12 Nov 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 This role supports the Operations Quality function within Advanced Surgical Instruments (ASI), specifically supporting the Stapling product families in a manufacturing environment focused on ensuring product quality, process performance, and compliance across production operations. The team partners closely with Engineering, Manufacturing, and cross-functional stakeholders to develop and maintain quality systems, resolve complex quality issues, and drive continuous improvement initiatives that support product reliability and operational excellence. This position is based in North Haven, Connecticut and requires onsite presence five (5) days per week. Minimal travel is expected.                     As an Operations Quality Engineer II, you will serve as a quality leader supporting manufacturing operations, engineering initiatives, and quality system improvements. This role is responsible for driving product and process quality, leading complex investigations and improvement projects, and partnering cross-functionally to ensure compliance, operational excellence, and product reliability. Primary Responsibilities • Support quality engineering initiatives that improve product quality, manufacturing performance, and quality system effectiveness. • Partner with manufacturing and engineering teams to establish, maintain, and enhance quality standards and control methods. • Develop and implement inspection, testing, validation, and monitoring strategies for products and production processes. • Analyze quality, process, and production data to identify trends, investigate issues, and drive corrective and preventive actions. • Execute root cause investigations and ensure effective implementation and verification of corrective actions. • Support regulatory, internal, and external audit readiness through compliant documentation and quality system execution. Required Qualifications • Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience OR Master's degree with 0 years of quality, manufacturing, or engineering experience. Preferred Qualifications • Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments, including supporting quality systems. • Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards. • Experience with process validation, test method validation, and/or equipment qualification activities. • Experience conducting root cause investigations, implementing corrective and preventive actions (CAPA), and analyzing quality/process data using statistical and problem-solving tools. • Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies; related certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma preferred. • Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.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