QA Senior Director - Medical Device

* Responsible for the global quality management and regulatory strategy, built with the cross-functional business partners, based upon a deep understanding of business needs.
* Establish appropriate Global Quality organizational structure. Determine key technical and leadership needs for immediate team members. Coach team members to ensure effective ongoing career assessment and development plans are executed across the entire organization.
* Oversee the interpretation of global governmental compliance guidelines, regulations and standards. Provide guidance, expertise and direction in developing any related strategies and processes. Provide clear and concise direction to key stakeholders of company to develop or change policies and procedures to ensure compliance.
* Bring forward best practices in quality engineering, systems, and services and works with project teams. Ensure an integrated process with R&D, Clinical, Regulatory and Manufacturing as well as other strategic partners in the business.
* Responsibility for oversight of the establishment and enforcement of global regulatory policies and procedures for completing procedures and other regulatory activities across divisions and sites.
* Lead the entire Company through change and ensure integration of efficient and effective new methods, processes and systems.
* Seeks feedback on continual improvement within and outside the quality organization and is a strong advocate for quality team innovative ideas and suggestions for increased efficiencies and eliminating non-value added processes and programs.
* Formulate and execute quality department budget and manages expenses to approved budget.
* Is a champion for quality in the company and leads efforts to facilitate progress.

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