Quality Systems Specialist

Quality Systems Specialist Support the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with FDA, ISO 13485, and other regulatory requirements. Key Responsibilities Develop and maintain quality programs, systems, processes, and procedures. Interpret and apply internal policies, regulatory, and governmental requirements. Collaborate with cross‑functional teams to perform process analysis and ensure regulatory compliance. Support internal and external audits and inspections, including FDA inspections and Notified Body audits; assist with audit preparation, documentation, response coordination, and follow‑up of observations. Act 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. Maintain and update quality assurance programs, procedures, and policies. Participate in continuous improvement initiatives and promote best‑practice sharing across functions. Assume QMS governance responsibilities, supporting implementation and maintenance of FDA 21CFR Part820 and ISO13485. Coordinate internal and external audit and inspection activities, including documentation collection and logistics. Maintain the Operations Quality Walk (OQW) program; conduct floor assessments, identify gaps, track corrective actions, and drive improvement. Manage SAP QM Local Data Administrator (LDA) activities, ensuring data integrity and compliance. Apply structured problem‑solving tools, root‑cause analysis, and CM methods to address quality issues. Support quality system projects and collaborate with cross‑functional teams to achieve objectives. Assist in Quality Management Review (QMR) activities by preparing reports and facilitating discussions. Minimum Requirements Bachelor’s Degree and a minimum of 2 years of relevant experience, OR an advanced degree with 0 years of relevant experience. Experience with FDA 21CFR Part820 and ISO13485. 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 the United States, the degree must satisfy the requirements of 8C.F.R. §214.2(h)(4)(iii)(A). Nice to Have Additional years of experience with FDA 21CFR Part820 and ISO13485. Advanced experience in audit and inspection readiness. Strong proficiency in CAPA and quality documentation. Experience in MDSAP or other global audit programs. Knowledge of TrackWise and other quality management software. Proficiency in PLM and ERP systems. Physical Job Requirements Regular independent mobility. Frequent use of a computer and communication with peers and co‑workers. Ability to comply with credentialing requirements for patient‑facing staff, if applicable. Equal Employment Opportunity Medtronic is an equal opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. For more information about EEO policies, please see the large notice above. #J-18808-Ljbffr MED Medtronic Inc