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 The Quality Engineer II supports the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group and Enterprise Operations. The Quality Engineering function supports manufacturing operations through process validation, quality system execution, and maintenance of quality standards for medical device manufacturing. This role is 100% onsite at the North Haven, CT manufacturing site, five days per week.                     The Quality Engineer II provides quality engineering support for manufacturing operations, with a primary focus on process validation and quality system execution. This role partners with Engineering and Manufacturing to maintain product and process quality, execute validation activities, address nonconformances, and ensure required quality documentation is complete and compliant. Primary Responsibilities • Develop, apply, and maintain quality standards and protocols for manufacturing processes and products. • Execute process validation activities across the validation lifecycle, supporting compliant and reliable manufacturing processes. • Partner with Engineering and Manufacturing to establish and maintain quality standards and resolve product and process quality issues. • Develop and implement inspection, testing, and evaluation methods for products, materials, processes, and production equipment. • Perform quality assurance testing and statistical analysis to evaluate process and product performance. • Investigate nonconforming products or materials and support corrective and preventive action (CAPA) activities. • Ensure corrective measures meet reliability standards and associated quality documentation complies with requirements. • Support quality activities across production control, product evaluation, reliability, incoming materials, and process quality. Required Qualifications • Bachelor’s degree in Engineering, Science, or a technical field with 2+ years of Engineering and/or Quality experience OR advanced degree in Engineering, Science, or a technical field with 0 years of Engineering and/or Quality experience Preferred Qualifications • Bachelor’s degree in Chemical, Biomedical, or Mechanical Engineering; advanced degree preferred. • Manufacturing environment experience. • Process validation experience across the validation lifecycle, including Installation Qualification (IQ), Operational Qualification (OQ), Test Method Validation (TMV), and Performance Qualification (PQ). • Corrective and Preventive Action (CAPA) experience. • Experience with Minitab statistical software and/or Six Sigma training. 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 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 this job description are representative of those that must be met by an employee to successfully perform the essential func