Directorm Quality Assurance Medical Devices

Our client is a rapidly expanding manufacturer of Medical Devices and Pharmaceuticals. Because of this growth, they seek a Director of Corporate Quality Assurance. This person will be responsible for managing the development, implementation and maintenance of quality assurance systems and activities. The Director will also oversee generation and review of documents used in Good Manufacturing Practices, manage all aspects of product quality and compliance with Federal and International Regulatory requirements for all operations.
REQUIREMENTS
* A degree in science or engineering.
* 8 plus years experience in an FDA regulated industry, either medical devices or pharmaceuticals as a Quality Assurance/Control professional.
* 5 plus years experience as a manager in Quality Assurance, Quality Control with product release responsibilities and post market QA responsibilities.
* 5 plus years experience supervising Quality Assurance Professionals and Quality Control Inspectors.
* Excellent knowledge of FDA QSR, ISA Quality Standards, principles of quality control inspecting/testing of medical devices.
* Proven experience working with suppliers of medical devices and stainless steel instruments.
* Excellent skills in conducting quality system audits (internal and external) and manging corrective actions to completion.
* Ability to analyze complex issues, perform root cause investigations and prepare written report of findings.