Director, Quality Assurance & Regulatory Affairs

CITY: Wauwatosa STATE: Wisconsin COUNTRY: USA Essential Functions (Responsibilities):
This position will drive the vision, strategy management visibility and evolution of the Quality Management System (QMS) for the Global Diagnostic Ultrasound & IT (DUIT) business. You will partner with the DUIT business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle. You will drive training, enhancement and adoption of the QMS framework and tools within the business. You will provide effective guidance and oversight for quality processes, as well as owning key decisions for the total product life cycle. You will insure compliance to existing US, EU, Canadian and Asian Quality Systems Requirements. You will translate new industry trends and requirements into business policies and practices across the DUIT business. You will manage internal and external audits across DUIT sites to ensure compliance as required by the business and reulatory agencies. You will manage a globally dispersed team of QA/RA professionals.

Qualifications/Requirements:
* BS/BA in Engineering or Scientific discipline
* 7+ years experience working in a Quality Management role in a regulated interface, which includes previous interface with FDA.
* Strong knowledge of quality systems (ISO, GxP, FDA)
* Previous people management experience
* Previous work experience in a manufacturing/engineering environment
* Previous work experience in a large, complex organization with global scope.
* Demonstrated ability to drive change within organization; strong influencing skills and ability to deal with important issues.
* Willingness to travel globally, approximately 20%
* Willingness to work in an office in our location in Wauwatosa, Wisconsin

Desired:
* Current background/work experience with medical device business; pharmaceutical industry also a possibility
* Experience building a Quality Management System from the ground up
* Professional certification in Quality Assurance or Regulatory Affairs
* Strong written and oral communictions at all levels of organization
* Six Sigma training and/or certification

General:
This dynamic leadership role will shape the strategy and create the operating structures for the global quality system within our Diagnostic Ultrasound and IT business. This global business is headquartered in Wauwatosa, Wisconsin, with additional locations in Europe and Asia.


We offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer.