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Vice President Quality Assurance
Location: Northeast

Will have responsibility for quality of multiple manufacturing sites and other
multi-Divisional functions. Will be responsible for all quality assurance systems, implementation of corporate policies and development of plant policies and controls for the assigned areas of responsibility. Will ensure that internal processes and metrics are aligned to create highest product quality and competitive advantage. He/she will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to
achieve business objectives. Additional responsibilities include: Provide leadership and strategic direction to the quality function , and will serve on the Corporate Quality Council. Ensure proper interface of the quality function to manufacturing, product registration, R&D and marketing. Build strong relationships with major Corporate customers – building, enhancing and ensuring quality awareness. Collaborate with manufacturing and other functions to ensure that quality standards and GMP compliance are met and maintained. Develop and monitor appropriate metrics to track quality and process improvement. Build a matrix organization to define and achieve objectives and drive accountabilities at each level. Develop the required organizational processes and competencies, which ensure that quality is integral to Corporate goals.
Be actively involved in the development of assigned Divisional business strategy. Position requires a seasoned professional with a minimum of 8 – 12 years of experience in Class II/III medical device companies. Must have a track record of success and a broad understanding of contemporary quality practices to the position. This individual will have led the implementation of a total quality initiative and understand the dynamics of creating lasting organizational change. In addition, he/she will have:
Proven expertise in the design and implementation of quality processes in a world-class device manufacturing organization.
Developed an organization culture that promotes and sustains quality as an element of superior business performance. Technical knowledge of product design, manufacturing, process design and improvement.
A global perspective and understanding of medical device quality assurance practices and requirements.
Ability to effectively relate the quality function to the business as a whole. An engineering, science or operations management undergraduate degree is required. Advanced degree(s) are a significant plus.