Job Title – Quality Engineer
Job Location – Bothell WA
Length – Contract (6 Months+)
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
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.
APN Software Service INC