The position of Advanced Quality Engineer is responsible to represent quality on design teams and assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to product quality, safety and efficacy. This individual will be an active team member and collaborator on new product development and product enhancement project teams for implantable medical devices.
Summary of Position with General Responsibilities:
- Support design and development activities for new product development including regulatory submissions.
- Lead product and process risk assessment activities such as Hazards analysis, and Design Failure Modes & effects Analysis (DFMEA).
- Support design validation and process validation activities.
- Lead shelf life/stability testing activities for new products.
- Develop, document and validate inspection and test methods to support design verification/validation, in-process inspection, and final inspection activities.
- Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities.
- Evaluate product complaints and initiate corrective actions as needed to improve product quality and work with manufacturing facilities in resolving quality issues.
- Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
Additional Desirable Qualifications Skills and Knowledge:
- Bachelor Degree in Technical discipline required.
- 3 years minimum experience in Quality Engineering discipline including design controls, product/process validation, and technical problem solving.
- Strong design control experience in a medical device environment.
- A high level of competence in Quality Technology including statistical techniques and six sigma tools.
- Applied knowledge of the requirements of FDA QSR’s and ISO Quality Systems.
Demonstrated collaboration and leadership skills on New Product Development Teams.
CQE and/or Six Sigma certification a plus.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...