Management of Advanced Quality Engineering for a Franchise that is responsible for supporting the development and manufacturing of new and modified products, establishment of quality systems for the effective control of these products and resolution of quality and manufacturing problems which arise during manufacturing.
Summary of Position with General Responsibilities:
Design Assurance: To support new product design and development by:
Quality Engineering: To support the manufacture of new and existing products by:
- Providing design input during the design and development of new products.
- Evaluation and approval of new product designs, specifications and product test procedures.
- Designing and executing statistical engineering experiments to compare design alternatives, compare proposed product with competitive products and evaluate performance.
- Co-ordinate biocompatibility testing on all new materials.
- Development of test methods for the adequate evaluation of designs.
- Final Design Verification of all new and modified products.
- Oversee and/or conduct Design Failure Modes & Effects Analysis for product risk assessment.
- Conduct both accelerated and real time shelf life testing to support extension of expiration dates.
- Providing the smooth transition of new products to manufacturing through the continuous review of all quality systems, inspection data and product yields.
- Mentoring, coaching and development of AQE personnel.
- Development of skill sets in the AQE department based upon the company’s changing needs.
- Developing process and product controls to assure the consistent manufacturing of products to established specifications.
- Validating all processes and equipment that may be important to the function of product being manufactured in order to assure reliability, consistency and compliance with FDA Regulations.
- Investigating and providing leadership in resolving product quality problems that occur in the manufacturing processes.
- Support failure investigation process to identify root cause of product, process, and system non-conformances in order to drive continuous improvement as well as corrective and preventive actions.
Additional Desirable Qualifications Skills and Knowledge:
- Bachelor of Science in Engineering.
- Minimum of 8 years experience in a Product Development environment.
- 1-3 years experience managing Sr. level AQE’s in an Engineering environment.
- Experience with design controls and statistical quality control
- Minimum of 3 years experience in medical device industry.
- Ability to travel domestically and internationally.
MS Degree preferred
ASQ certification (CQE, CQM) preferred
C. R. Bard - 2 years ago
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