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Quality Engineer - Medical Devices

Company: Alpha Consulting
Location: Irvine
Posted on: January 13, 2021

Job Description:

QUALITY ENGINEER MEDICAL DEVICESIRVINE, CARequired Skills: * Bachelor's degree or higher in an engineering or scientific discipline* 5 years of experience in the medical devices sector, with experience in Class III preferred* 1 year dedicated experience with product risk per ISO 14971 in the medical devices sector* Ability to interpret basic statistical data and graphs* Experience following the requirements of ISO 13485 and QSR* Excellent writing and presentation skills* A critical eye for detail* Ability to work cross-functionally* Pluses: * Project management experience* CQE or risk management certification* Experience interacting with regulatory agenciesProject Description: An ideal candidate for this role is someone who can thoroughly assess potential product risks and summarize them in a clear, concise manner; a natural ability to categorize information and see possibilities beyond the obvious would be helpful.Successful candidates will have the following types of experience:* This role is part of the team that manages post-market medical device risk.* As such, it is mandatory to have hands-on experience executing medical device risk management in alignment with ISO 14971 and QSR.Primary responsibilities of this position include aggregating and presenting periodic risk data, generating risk management reports, collaborating with technical experts to update risk documents (e.g., FMEAs), and assessing hazards.* Evaluate risk. Aggregate and analyze data from multiple sources (e.g., signal detection, medical review, etc.) and identify common trends.* Escalate risk. Use sound judgment to identify novel events and new risks, then make recommendations to escalate or provide rationale regarding why escalation is not necessary.* Champion collaboration. Actively engage with product engineers and medical officers across the organization to ensure evaluation of product risk considers multiple inputs. This 12+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.com ALPHA'S REQUIREMENT #21-00033MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR

Keywords: Alpha Consulting, Irvine , Quality Engineer - Medical Devices, Other , Irvine, California

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