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Medtronic

ISR-M Kefar Sava, Israel

Quality Program Manager.

REMOTEPRODUCT
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 a 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. By providing a fast and reliable intraprocedural physiologic assessment of the entire coronary tree, the technology helps physicians make informed treatment decisions for every patient. As a Quality Program Manager, you will play a critical role in the integration of CathWorks quality systems and processes into Medtronic's global quality framework. Based in Kfar Saba, this onsite position is responsible for ensuring the seamless alignment of design controls, CAPA, complaints handling, software development lifecycle, and regulatory compliance processes. Working across multiple functions, you will help drive quality excellence, regulatory readiness, risk mitigation, and process harmonization while supporting the successful integration of innovative digital health technologies into the Medtronic portfolio. Responsibilities may include the following and other duties may be assigned: Work with the Integration Lead on integration planning for quality systems, processes, and documentation, ensuring alignment with Medtronic’s QMS, regulatory requirements, and integration objectives. Lead the mapping, migration, and harmonization of CathWorks’ quality processes, including document control, training, audits, CAPA, complaints handling, and design control activities, ensuring compliance with FDA, MDR, ISO, and Medtronic standards. Oversee CAPA and complaints management processes, including root cause analysis, corrective and preventive actions, regulatory reporting, and continuous process monitoring. Provide oversight of software development lifecycle processes, including requirements management, design reviews, validation, testing, and software design controls in regulated environments. Ensure all quality activities comply with applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk management, audit readiness, and support for internal and external audits. Facilitate communication, training, and stakeholder engagement across CathWorks and Medtronic, identify process gaps, drive continuous improvement initiatives, and monitor integration progress through metrics and regular reporting. Required Knowledge and Experience: Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred. 7+ years of experience in medical device quality management, including QMS integration, design controls, CAPA, complaints management, and software validation. Strong knowledge of FDA regulations, MDR ISO 13485, and 21 CFR Part 11 requirements. Demonstrated project management and leadership skills, with the ability to drive cross-functional initiatives. Excellent communication, stakeholder management, and change management skills, with the ability to influence and engage diverse stakeholders. Previous experience in integration activities or large-scale QMS harmonization projects, working with electronic QMS platforms and software development lifecycle processes in regulated environments, and familiarity with Software Design Controls 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 never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. ‌ This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [email protected] To request removal of your personal information from our systems please email [email protected]
Pay
Not stated
Where
ISR-M Kefar Sava, Israel
Work
Remote
Type
Not stated
Posted
22 Oct, 2026
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