Senior Director, Global Quality (Finance)

Senior Director, Global Quality (Finance)Careers That Change Lives The Senior Director, Global Quality is a key leadership position supporting and driving growth through innovation, while generating a strong Quality culture and customer first mindset. This role will be key in building and strengthening partnerships across the business by providing quality support and solution-based decision making to enable delivery of the product roadmap, maintain product and quality system compliance, prevention of quality issues and drive continuous improvement. The Senior Director of Global Quality for Renal Care Solutions (RCS) will provide strategic leadership and have the technical/tactical skills to manage functional growth. This position is responsible for leading and managing quality assurance of medical device products, combination product, and pharmaceuticals. Renal Care Solutions is a business within Medtronic that is working to advance dialysis and renal care through innovative design. This is a cross-functional, collaborative operating unit (OU) to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. LOCATION: Remote option may be considered A Day in the Life Responsibilities may include the following and other duties may be assigned: Through strategic and proactive leadership, develop and implement the RCS business and product Quality strategy that drives significant improvements, is aligned with the business and Enterprise strategic priorities, and generates a strong Quality culture Responsible for ensuring that quality and reliability goals are set early in the design process and development practices incorporate current and appropriate worldwide regulatory compliance expectations (including FDA QSR, ISO 13485, ISO 14971, CMDR, and European Medical Device Directive) for design controls and risk management The position leads a global Quality team dedicated to driving significant improvements aligned with OU and Enterprise strategic priorities. The position delivers a 'Quality begins with Me' culture and is accountable for predictive and proactive 'total product lifecycle' product superiority and patient safety Ensure the implementation of processes to enable the highest reliability in new product introduction programs according to DRM (Design for Reliability and Manufacturability) principles and in collaboration with cross-functional / cross-business partners Responsible for assessing risk and Field Corrective Action decisions; establish recall strategy Responsible for regulatory compliance and providing oversight to the QMS(s) under the purview of the RCS business Partner with related Quality functional groups such as manufacturing quality, post-market vigilance, quality system and internal audit to drive improvements in product quality and quality system compliance Establish, maintain, and update quality systems policies and procedures to ensure that products and processes meet applicable standards and specifications Ensure RCS business quality standards align to Global standards Implement processes and policies in compliance with enterprise quality strategies to ensure financial and strategic goals are attained Accountable for compliance of quality system and lead the interaction with FDA and notified bodies during audits and site inspections Leverage and actively support quality services provided through established Shared Service Level Agreements with Enterprise Core Quality Services, Operations Quality, and Regions Create and foster a diverse, ethical, accountable, and competitive culture Design organization structure aligned with required capabilities to deliver quality Lead and manage Quality Assurance Managers in multiple locations who provide quality engineering support in design and development of medical devices, combination product, and pharmaceuticals. Manage talent through learning and development activities for direct and dotted-line Quality reports Coordinate, review and approve department budgets and resource allocations Must Have: Minimum Requirements: Bachelor's degree Minimum of 15 years of relevant experience with 10+ years of managerial experience , or Advanced Degree with a minimum 13 years prior relevant experience, minimum of 10 years of managerial experience Nice to Have: Preferred Requirements: Technical Knowledge: In depth practical knowledge of software quality engineering, ISO-14971 for risk management, FDA regulations, CMDCAS, JGMP, ISO 13485, and the Medical Device Directive. Ability to develop, socialize and execute strategies to drive business/customer value ASQ Certified Quality Engineer Six Sigma or Lean Certification(s) Experience with start-ups and / or fast paced product commercialization growth Ability to identify, develop and establish effective business processes compliant with regulatory and industry standards Strong business acumen and sound judgment to support and execute strategic plans Balanced risk management approach Strong interpersonal, planning and continuous improvement skills Ability to hire and develop managers and engineers to meet organization needs Ability to directly and indirectly manage teams and individuals to achieve high levels of performance Express, model, and reinforce integrity, transparency, accountability, and respect for people Create environment for open communication and enable strong relationships with Shared Services, Center of Excellence (CoEs), Regional partners, and business colleagues Ability to communicate effectively in multi-discipline environment, and across functions, cultures and levels of organization Extensive Design Quality experience across multiple products and geographies, including hardware, software, consumables, accessories, combination product and pharmaceuticals Salary Minimum: $200,000 Salary Maximum: $300,000 About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. 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 Day in the Life 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. Additional Information Posting Date: Jan 19, 2021 Travel: No