Reports To: Vice President, Quality Assurance and Regulatory Affairs

Responsibility and Authority: The Director of Quality Assurance has the authority and responsibility for ensuring that the requirements of 21 CFR Part 820 and ISO 13485 are implemented and maintained.

Scope of Duties / Job Description: • Management Representative to management for the company Quality System • The Director of Quality has the authority and responsibility for the quality system compliance to 21 CFR Part 820, ISO 13485:2003 and Canadian Medical device regulations • Supervises quality inspection functions and assures compliance to FDA, ISO, Canadian and company rules and regulations • Supervises the Quality Engineering function with responsibility for new product development support through Design Control, manufacturing support for cost reduction and productivity improvement and product quality improvement • Oversees the product release function • Participates in FDA and Notified Body Audits • Investigates customer complaints to determine root cause and appropriate corrective action • Oversees the CAPA system • Manages the company calibration system • Prepares for and participates in the management review with Senior Management to ensure the continuing suitability and effectiveness of the Quality System and Quality Policy. • Maintains documentation of management reviews • As member of the management team, contributes in formulating and establishing Quality Plans, organizational policies and procedures for company • Provides leadership not only from a Quality and Compliance perspective but also from the business need perspective. • Stays current with regulations and technical developments in the industry • Collects quality metrics, identifies areas for quality improvement and institutes programs to improve customer satisfaction • Oversees internal and external audits and assures that appropriate corrective action is implemented in a timely manner • Establishes and maintains the budget for the Quality Systems Department • Develops, implements, and coordinates, through support staff, a quality plan to prevent or reduce defects in new or existing products working with the Manufacturing Engineering function • Establishes and monitors measurements indicative of the effectiveness of Quality System. • Through internal quality audits, verifies compliance of practices and procedures to the documented system and determines the effectiveness of the quality system. • Participates in validations including, but not limited to, new products, changes to existing products, processes, and equipment • Participates in Quality System Training for the entire company • Other duties as assigned Working Conditions: • Approximately 15% travel, including Domestic and International • No medical conditions preventing access to a controlled environment room Education / Training: • B.S. in Electrical Engineering or a biological science; M.B.A. or M.S. or equivalent experience preferred • 8-10 years of progressive management responsibility with at least 5 years in the medical device industry or equivalent experience Other Requirements: • Knowledge of Good Manufacturing Practices (GMP), applicable Quality System Regulations, ISO 13485:2003, and CMDCAS • Prior experience with microprocessor-based medical device instrumentation • Biocompatibility, shelf life, process validation, and sterilization validation knowledge • Must possess quality systems/compliance experience • Experienced with site FDA inspections • Ability to perform activities to support product development, manufacturing, and product/process release as identified by Senior Management