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St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, MN, St. Jude Medical employs more than 15,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We currently have the following position available in our Neuromodulation Division.
Educate, advocate, oversee and support QA and compliance operations ensuring that all applicable global Quality System laws, and regulations, together with business internal operating procedures, are identified, interpreted, communicated and applied without compromise by all concerned company employees and throughout the entire product development lifecycle
Major, On-Going Responsibilities: • Remain current on all regulatory environment changes and facilitate implementation to ensure compliance as required • Implement the Global Quality Management System • Develop and/or improve a system of metrics for the Quality System • Complete, monitor, analyze, and present Quality System data and trending to ensure quality system issues are identified, addressed and resolved • Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team. • Report to management potential systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR, NCMR, Audit reports, etc • Define Regulatory requirements and provide guidance and direction on the development, revision and/or maintenance of the quality system and business processes in compliance to applicable laws and regulations • Define Division and Corporate Quality System Requirements for Quality System Procedures • Verify and ensure compliance with the company's policies and procedures as well as Global Regulatory Requirements, such as FDA 21 CFR part 820, 803, 806, ISO 13485, AIMD, Canadian MDR, Brazil, Australia, Japanese regulations and other global regulations as appropriate. • Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. • Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility. • Identify Quality Initiatives and lead cross-functional teams to complete them • Represent NMD on Cross-divisional Teams to Develop SJM Enterprise Quality System Processes • Facilitate annual quality System Process Reviews to ensure sustainable compliance • Ensure understanding of the Quality system procedures and regulations through proactively developing and delivering training • Develop compliance and quality system strategies and be an effective member of cross-departmental Functional Teams to foster continuous quality compliance, cost, and proactive improvements. • Act as the company representative to support management during external inspections and participate in the management of external inspections • Under the direction of management take ownership for the coordination of specific projects, providing specific compliance and quality services. • Support and/or perform quality oversight and direction for CAPA activities • Develop Global Quality System Dossiers for Regulatory Approvals • Communicate with Regulatory Agencies on compliance related issues, reporting, or activities
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2 openings. Local Residents Preferred (No Relo)
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