Quality Engineer
$40 - $53 per hourThe Fountain Group
The Fountain Group is currently seeking a Quality Engineer for a prominent client of ours. This position is located in Santa Clara, CA. Details for the position are as follows:
Pay Range: $40 - 53/hr depending on experience
W2 Contract: 1 year with possible extension and/or conversion
100% onsite in Santa Clara, CA
- Join the Regulatory Operations Team, supporting them from Quality Systems + Compliance perspective - supporting Audits, owning CAPA's, labeling controls in Quality System, managing KPI's to ensure Regulatory processes are healthy.
- Will work on a few key projects - managing KPI dashboard reflecting health of Regulatory Quality system, and currently integrating a Quality System from a company acquisition - so at the product approval process. Experience supporting Audits would be great as we'll work on Audit preparedness - risk mitigation activities such as implementing mock audits for key regulatory documents.
- Team does a lot of investigational activities for CAPA's and NCMR's, determining mitigation strategies.
- Senior Quality background - Quality Systems requirements, Quality Systems compliance activities in Medical Device - ISO 13485, 21 CFR Part 800, EU MDR etc
- Bachelor's Degree in technical discipline
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Vacancy posted 3 days ago
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