Our medical device manufacturing client is currently seeking a Sr Biomedical Engineer for a 1 year contract.
This job will have the following responsibilities:
- Lead Sustaining Quality Engineering activities for EU MDR Compliance of Orthopedic Products. Individual will provide guidance to the Sustaining cross functional teams to ensure compliance to the company’s quality system and external standards. Individual will perform compliance gap assessments to new requirements, review & approve new and updated design control documents, and assist in OEM product activities. Individuals must be proficient in design controls. Individual must have attention to detail and work well in group settings.
- Review and approve risk documentation
- Review and approve remediated Design Controls
- Must be able to interact with suppliers if working on OEM
- Perform Gap Assessments by assessing current DHF documentation against EU MDR requirements
- Blue Print reading
- Technical Problem Solving
- QA Standards & Procedures