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.
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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.
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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.
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- This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
