Our client is seeking a Quality Engineer near Boston, MA!
Our client is a medical device company that is rapidly expanding with a recent new acquisition and multiple medical devices on the market in varying therapeutic areas. This company has been changing the way medical devices are used since 1983.
- Take care of day-to-day activities based on goals in accordance with corporate policies and goals that come with building high-quality medical devices
- Evaluate medical device failures, product complaints, and write summary reports
- Determine root cause and implement Corrective and Preventative Actions
- Evaluate risks in product design and the manufacturing process of medical devices
- Update the quality system based on non-conformities found during internal and external audits
- Review all non-conforming material reports for planning and disposition
- Evaluate supplier performance which is based on data collected at incoming inspection
- Bachelor’s degree in either biology, biotechnology, or biomedical engineering
- 2+ years of experience in the medical device industry
- Understanding of ISO13485, ISO10993, & ISO14971
- Experience with Microsoft Word, Excel, PowerPoint, and Outlook
- Must have strong oral and written communication skills