Quality Systems Specialist

Job description

We anticipate the application window for this opening will close on - 27 Jul 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 LifeAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. In this role as a Quality Systems Specialist, you will support the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory requirements. You will assist in audit readiness activities, support Quality Management System (QMS) processes, and contribute to continuous improvement initiatives. You will support internal and external audits, including FDA inspections, Notified Body audits, and other regulatory inspections, helping to maintain a state of inspection readiness and compliance. The Quality Systems Specialist supports the development, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and company requirements. This role partners with cross-functional teams to support audits and inspections, CAPA and compliance activities, Quality Management Reviews, Operations Quality Walks, SAP QM administration, and quality system improvement initiatives while helping maintain a state of inspection readiness and regulatory compliance. Key Responsibilities Support the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance. Interpret and apply internal policies, regulatory, and governmental requirements with guidance from quality leadership. Collaborate with cross-functional teams to perform process analysis and support adherence to applicable regulations. Support internal and external audit and inspection activities, including audit preparation, documentation, response coordination, and follow-up of observations. Assist as a point of contact during audits and inspections, ensuring timely communication and document retrieval. Prepare quality reports, metrics, and documentation, including CAPAs and quality records. Support requests related to regulatory, legal, or compliance matters as needed. Maintain and update quality assurance programs, procedures, and policies. Participate in continuous improvement initiatives and promote best practice sharing across functions. QMS Governance & Regulatory Expertise: Support the Quality Management System by assisting with implementation and maintenance of regulatory requirements, including but not limited to FDA 21 CFR Part 820, ISO 13485, and applicable company procedures. Support QMS harmonization efforts and compliance activities. Audit & Inspection Leadership: Coordinate and support internal and external audits and inspections by assisting with planning, document collection, audit logistics, and follow-up activities. Support inspection readiness efforts through routine assessments and compliance monitoring. Operations Quality Walk (OQW) Program: Manage the OQW program by coordinating routine floor assessments against established criteria. Identify compliance gaps, track corrective actions, partner with cross-functional teams to drive accountability, and ensure timely follow-up and continuous improvement activities. SAP QM (Quality Management) LDA Support: Manage SAP QM Local Data Administrator (LDA) activities, including support for material master data, inspection setup, and quality-related system configurations to ensure data integrity and compliance. Problem Solving & Continuous Improvement: Utilize structured problem-solving tools, root cause analysis, and continuous improvement methodologies to identify and address quality issues and improve business processes. Project Leadership & Mentorship: Support quality system projects and collaborate with cross-functional teams to achieve project objectives. Contribute ideas and recommendations for process improvements and compliance enhancements. Quality Management Review Support: Support Quality Management Review (QMR) activities by ensuring accurate data inputs, preparing reports, and facilitating discussions to drive compliance and continuous improvement at the leadership level. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum qualifications are evident on your resume. Bachelor’s Degree AND a minimum of 2 years of relevant experience, OR an advanced degree with at 0 years of relevant experience. Nice to Have 2+ years of experience with FDA 21 CFR Part 820 and ISO 13485. Experience supporting internal and external audits. Knowledge of CAPA, nonconformance, change control, and document control processes. Familiarity with Lean, Six Sigma, or continuous improvement methodologies. Familiarity with Medical Device Single Audit Program (MDSAP). Experience with quality systems software such as TrackWise (Sparta). Experience with PLM systems such as Agile or Windchill. Experience with SAP QM or other ERP quality management modules. 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 functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ 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 Medtro