Quality Engineer III
Company: Impellam Group N.A.
Location: Irvine
Posted on: January 12, 2021
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Job Description:
Quality Engineer IIIQuality Engineer III, Risk Management -
Medical DeviceAn 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.YOU
WILL:--- 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.YOU BRING:--- 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 agenciesSRG is an Equal Opportunity Employer - All
qualified applicants will receive consideration without regard to
race, color, religion, gender, national origin, age, disability,
veteran status, or any other factor determined to be unlawful under
applicable law.
Keywords: Impellam Group N.A., Irvine , Quality Engineer III, Other , Irvine, California
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