Warwick, Rhode Island
The position of the Advanced Quality Engineer/Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.
Summary of Position with General Responsibilities:
- Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors as required based on level.
- Lead or Support Quality Engineering Projects to improve Quality Systems and Procedures.
- Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions.
- Development of Risk Management Documents, including the DFMEA, while coordinating input from the other Design Sub-team members.
- Development of the Design Verification Protocol and Design Verification Report.
- Provide input into the product Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents as defined per Davol’s product development process.
- Support front end product innovation process activities to support new technology integration and transfer to new product development teams.
- Determine the degree of Biocompatibility testing required as per ISO10993 requirements.
- Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating.
- Lead Supplier part qualification activities.
- Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of test methods used to assess the safety and efficacy of devices.
Additional Desirable Qualifications Skills and Knowledge:
- Bachelor or Masters Degree in Engineering or Technical Sciences or equivalent combination of Bachelors Degree and related work experience.
- AQE (2-5) year’s minimum experience, Senior AQE (5-8) year’s minimum experience in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving.
- An appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.
- Applied knowledge of the requirements of FDA QSR’s and ISO Quality Systems.
CQE certificate from American Society for Quality a plus.
Ability to work with and motivate people.
Good oral and written communication skills.
C. R. Bard - 2 years ago
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...