Post Market Engineer

Winston Salem, NC 27105

Posted: 09/11/2019 Employment Type: Contract Industry: Entry Level Job Number: 95346
We' re hiring a Post-Market Surveillance Engineer for our Medical Device Manufacturing client in Winston-Salem! This position offers a competitive pay rate and will start out as a contract assignment, with the potential to lead to permanent employment. The responsibilities of the Post-Market Survellance Engineer is to collect, analyze, and report post market data, in compliance with national and international regulations and guidance. The Engineer will also monitor the performance of a medical device after the release to market and ensures post market surveillance plans and reports are completed and reported on time. Duties will also include collaborating with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process. The ideal candidate must have strong organizational and analytical skills, deadline driven, and must know EU and USA reporting. If you feel you would be a good fit for this opportunity and would like to learn more, contact us today!

Essential Functions & Duties
- Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports.
- Collect, review, and edit Post Market Surveillance data for Clinical Evaluation Reports.
- Generate plans and reports to ensure compliance with evolving regulations.
- Monitor, track, and communicate project progress to leadership.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Ability to prioritize workload and meet project deadlines.
- Generate responses to inquiries on PMS reports from various global regulatory authorities.

Qualifications:
- Bachelor' s degree in a technical discipline or communications, or equivalent work experience.
- 2-3 years related Post Market Surveillance experience required.
- Computer experience required with working knowledge of Microsoft Office programs.
- Proficient keyboarding skills.
- General product knowledge.
- Medical device industry regulatory requirements knowledge required.

Submit your resume online, or directly to jyeargan@theresource.Com, to be considered for this position. For additional information, please call or text our office at 336.970.5214.
While we appreciate all inquiries, only qualified candidates will be contacted for further information.
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