Quality Engineer - 2 Openings

Job Title – Quality Engineer 
 
Job Location – Bothell WA
 
Length – Contract (6 Months+)
 
Responsibilities:
 o Produce and review a wide range of quality documents including; procedures, reports, reviews, protocols and templates.
 o Create draft Risk Management process revisions and drive revisions for Product Risk Management documents for complainant EU-MDR documents
 o Provide Independent Reviewers for ongoing New Products Introductions projects to free up others to focus on process revisions
 o Gather and document Technical data for MDR EUDAMED UDI submissions
 o Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance and Marketing to develop EU-MDR documents
 
 Skills:
 o 10+ years of experience in Quality Engineering with experience in software quality. 
 o Must have experience working with regulations and standards auditing to and being audited to such. 
 o High level working knowledge of data analysis - comfortable with application of the 7 basic quality tools and typical statistical tools for Quality - SPC, sample size evaluation, DoE, etc. 
 o Experience working with product development - should understand concept and typical implementations of V model for development and have good technical writing skills. 
 o Understanding of requirements vs. specification and analysis of both 
 o Understanding of typical test strategies 
 o Understanding of Design Verification/Validation 
 o Education: Education: Bachelor's /Master's degree in Engineering 
 o Experience with/Knowledge of: 21CFR820, ISO13485:2016, euMDD/euMDR, ISO14971: 2007/2021 and medical device manufacturing. 
 o Additional preferred Qualifications: 
 o CQE certification 
 o Ultrasound product experience.
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com
609-357-9180 (Direct)

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