Quality Engineer

  • location: Bothell, WA
  • type: Contract
  • salary: $60 - $70 per hour
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job description

Quality Engineer

job summary:
Excellent Opportunity for a Quality Engineer in Bothell, WA

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

 
location: Bothell, Washington
job type: Contract
salary: $60 - 70 per hour
work hours: 8 to 5
education: Bachelors
 
responsibilities:
  • Produce and review a wide range of quality documents including; procedures, reports, reviews, protocols and templates.
  • Create draft Risk Management process revisions and drive revisions for Product Risk Management documents for complainant EU-MDR documents
  • Provide Independent Reviewers for ongoing New Products Introductions projects to free up others to focus on process revisions
  • Gather and document Technical data for MDR EUDAMED UDI submissions
  • Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance and Marketing to develop EU-MDR documents
 
qualifications:
  • 10+ years of experience in Quality Engineering with experience in software quality.
  • Must have experience working with regulations and standards auditing to and being audited to such.
  • 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.
  • Experience working with product development - should understand concept and typical implementations of V model for development and have good technical writing skills.
  • Understanding of requirements vs. specification and analysis of both
  • Understanding of typical test strategies
  • Understanding of Design Verification/Validation
Experience with/Knowledge of: 21CFR820, ISO13485:2016, euMDD/euMDR, ISO14971: 2007/2021 and medical device manufacturing.

 
skills: Education: Bachelor's /Master's degree in Engineering

Preferred:

  • CQE certification
  • Ultrasound product experience

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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