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Quality Engineer II

Location: Cordova , Tennessee
Job Category:

Quality Engineer II
Cordova, TN
12+ month contract 

• • Compliance Engineer [ME, QE, R&D] – Data Analytics

The ideal candidate has 10+ years of medical device experience in an engineering role.
• The compliance engineer has an undergraduate degree in a science or engineering discipline.
• - Proficient in Microsoft Office
• - Previous experience or internship in regulatory filings, preferred
• - Technical writing aptitude, a must
• - Coordinates and documents internal regulatory processes
• - Compiles and prepares material for submissions to regulatory agencies

• - Demonstrated experience and communication with notified bodies, US and International
• - Knowledge of international and consensus standards for medical devices
• - Ability to work cross functionally to achieve a common goal
• - Collect and coordinate information for preparation of technical presentation to regulatory agencies or commercial partners
• - Review labeling and labels for compliance
• - Responsible for timely registration
- Contacting and maintaining relationships with external stakeholders
- Building / completing remediation activities for design history files
- Experience in the creation, revision, and maintenance of risk, production, or design specifications, as applicable

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