Company Description:

Actively seeking a Quality Systems Manager in the medical device industry.  This is not a startup and would not be a right fit for the type of engineer that would be wanting to work for a Google type of FB type of Co.  However, IS a solid, cutting edge, growing company that is financially sound and has a quality reputation.  The type of individual would want to work for a company that can truly make life impact on others based on their type of technology. 
 

Our confidential client is looking for a leader in in the area of QA Management with 5 plus year of experience in Manufacturing, Engineering, or Quality/Continuous Improvement environment.  Experience with supervision of technical and regulatory professionals is highly desirable.  This role will carry the responsibilities of ensuring compliance to the overall Quality Management System and to drive Continuous Improvement.  You will be providing coaching, mentoring, and leadership to the plant staff and leading the review process.  Our client wants someone that understands domestic regulation as well as international standards and requirements.   Someone who prides themselves on quality improvement process in overall data analysis, improvement projects, and process capability to improve key metrics as measured by the product/process quality dashboard.  This role will handle complaint resolution to ensure customer responsiveness and product / process improvements.  You will be responsible for the overall quality plan development and execution for manufacturing site New Product Development, ensuring successful product design transfer.  Lead qualification and monitoring tasks for manufacturing site key suppliers to ensure effective supplier performance in the manufacturing process.  The position requires a level of authority to conduct and direct required activities in a positive and proactive manner.  Examples of this are: Quality planning, complaint management, production and process controls, CAPA management, supplier management, and new product design transfer.   The position requires a B.S. in Mechanical Engineering, Electrical Engineering, or similar engineering field or in other pertinent science or technical field.

Desirable Skills: Proven leadership ability to manage a team, make decisions and deliver results Ability to solve problems at an operational and strategic level, manage multiple priorities and conduct data analysis Working knowledge of ISO 9001, ISO 13485, and FDA GMPs CQE, CQA, CQMgr., Six Sigma or Lean Ability to set goals and meet project deadlines Effective communication skills, both oral and written are required Experience with Class III or significant Class II device