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.\n‌ 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 .\n‌ 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. Salary ranges for U.S (excl. PR) locations (USD):$75,200.00 - $112,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance , Health Savings Account , Healthcare Flexible Spending Account , Life insurance, Long-term disability leave , Dependent daycare spending account , Tuition assistance/reimbursement , and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match , Short-term disability , Paid time off , Paid holidays , Employee Stock Purchase Plan , Employee Assistance Program , Non-qualified Retirement Plan Supplement (subject to IRS earning minimums) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans 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. If you are applying to perform work for Medtronic, Inc. 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Quality Systems Specialist