18 Month FTC
This position will support the execution of the Site's Medical Device Regulation Compliance by providing quality support to the MDR project. The successful individual will drive the flawless and compliant execution of the assigned processes to meet business needs while ensuring the quality processes are updated supported throughout the project.
* Work with cross functional team to generate documentation for technical file submissions.
* Is responsible for providing quality support and expertise to the project manager.
* Work directly with the various owners/teams across the globe to ensure investigations/actions are implemented and accurately documented to plan.
* Serve as technical expert with regard to questions or issues related to the processes they are responsible for.
* Provides technical consultation to others pertaining to problems and leads technical project deliverables.
* Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
EDUCATION AND EXPERIENCE
* Third level qualification (preferably Science or an Engineering related discipline) and 2 or more years of related experience.
* Knowledge of the applicable regulations and working knowledge of other major regulatory agencies regulations and guidance's is highly preferred.
* Previous experience or training in Process Failure Mode and Effects analysis desirable.
* Proficiency with MS Office, including Word, Excel and Power Point, Adobe, SharePoint and ability to quickly learn new systems is required.
* People management experience is desirable.
* Lean or Six Sigma qualification is desirable.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists