Quality Engineer - Medical Devices
Company: Alpha Consulting
Location: Irvine
Posted on: January 13, 2021
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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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