QUALITY ASSURANCE SPECIALIST - MEDICAL DEVICEProject Description:
Consultants will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes. Required Skills:
- Minimum of a Bachelor's Degree is required, with preference for natural sciences or engineering.
- 5+ years' experience in Medical Device Quality Systems and/or Quality Assurance.
- Experience with Documentation Control and Change Control.
- First-hand experience with implementation of EU MDR requirements.
- Strong technical writing skills.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen: URL blocked - click to apply
ALPHA'S REQUIREMENT #19-01162
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Total Quality Management
Provide Technical Guidance