Quality Engineer

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 CathWorks, recently acquired by Medtronic, is the leader in digital health innovations that improve the lives of patients globally. The CathWorks FFRangio® System combines AI and computational science to obtain physiologic information from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with a quick and reliable intraprocedural physiologic assessment for the entire coronary tree, making it practical for every patient. As a Quality Engineer, you will play a key role in supporting day-to-day quality activities while helping harmonize quality and regulatory processes across the organization. This position focuses on design controls, CAPA, complaint handling, software development lifecycle activities, and regulatory compliance within a regulated medical device environment. You will collaborate with cross-functional teams to ensure quality system requirements are effectively implemented, maintained, and continuously improved, supporting the delivery of innovative technologies that advance patient care. Responsibilities may include the following and other duties may be assigned: Assist in aligning and implementing design control processes, including requirements management, design reviews, verification/validation, and traceability. Support the mapping, migration, and harmonization of quality system processes, including document control, training, audits, and related quality activities; support internal and external audits as applicable. Participate in the integration and standardization of CAPA and complaints handling processes, ensuring effective root cause analysis, corrective and preventive actions. Support software development lifecycle processes, including requirements management, design reviews, validation, and testing. Ensure all integrated processes meet applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk analysis, and audit readiness. Assist in updating and maintaining quality documentation, provide training to stakeholders on new or revised processes, identify process gaps, and support continuous improvement initiatives. Required Knowledge and Experience: Bachelor’s degree in Engineering, Life Sciences, or a related field. 3+ years of experience in medical device quality engineering, including QMS, design controls, CAPA, complaints management, and software validation. Working knowledge of FDA regulations, MDR, ISO 13485, and 21 CFR Part 11 requirements. Experience with software development lifecycle processes in regulated environments is an advantage. Strong analytical, communication, and teamwork skills, with the ability to work effectively in cross-functional environments. Experience with QMS integration or harmonization projects and electronic QMS platforms would be considered an advantage.   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.  ‌ Recruitment Fraud Alert   We are aware of phishing scams targeting job seekers. Please keep the following in mind:  Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.  Medtronic will