Director, Quality Engineering - Medical Device 9/3/2016
JOB DESCRIPTIONAPPLY TITLE: Director, QualityEngineering, Medical Devices
The Director, QualityEngineering will be responsible for guiding, directing and managing the qualityengineering team responsible for providing quality support for Product Life Cycle Management, focusing on design controls, including new product development and ongoing product support.
1. Establish strategic vision, direction and management of the Quality Engineering Group currently a team of 5.
2. Oversee all Quality Support for the Product Lifecycle Management program
3. Develop and implement appropriate risk management strategies and programs
4. Develop plans for integration of new products from transfers and mergers into the corporate system
5. Develop quality engineering function capable of providing guidance and tools for product development and problem solving using appropriate tools
* Requires a Bachelor's Degree in a technical/science/engineering field.
* A minimum of 15 years of experience in the medical device industry including 10+ years of extensive supervisory and team development experience.
* Knowledge of national and international regulations applicable to medical devices including; Human Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
* Six Sigma black belt a plus.
* Ability to analyze and interpret all regulatory and quality guidelines needed
* Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards