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Leads a team of employees in the achievement of organizational goals, project goals, and career goals. Recruits, hires, supports, and develops a high performing team.
Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Product Inquiry Reports (PIRs), and Corrective and Preventive Actions (CAPAs). Expected to facilitate high performing teams working towards common goals and timelines.
Reviews, approves, and creates Quality System records for NCEPs, PIRs, and CAPAs. Would represent NCEPs, PIRs, and CAPAs in internal and external audits directly or with team.
Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. Represents the team at key global and divisional leadership forums.
Develops department budget and monitors spending. Determines appropriate staff levels and schedules. Works with cross-functional partners to understand priorities and plans resource allocation accordingly.
Leads collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not.
Presents updates in formal and informal reviews with all levels of the organization including high senior leadership at Boston Scientific.
Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs, CAPAs, and PIRs. May include consulting across other BSC divisions.
Drive improvement in Field CAPA team directly and at large in Global Communities of Practice to foster cross-communication, best practices, and improvement to investigational processes and outcomes.
Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Monitors and ensures compliance with company policies and procedures.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Design Assurance CAPA Manager - Cardiac Rhythm Management and Diagnostics (CRMDx)
Arden Hills, MNPosted 6 days ago