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Orthopedicjobs is seeking a Quality Assurance Engineer to develop and implement methods for process control and product testing within a hybrid work environment. The ideal candidate should have a background in mechanical or biomedical engineering, with 2-6 years of experience in design quality assurance, specifically in the medical device sector.
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Job Summary
Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
This position involves in-depth knowledge of EUMDR requirements, collaboration with cross-functional teams, and proactive management of regulatory compliance throughout the product life cycle.
Review quality assurance documentation to support mainly product sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.
Matching Summary
Match Score: 75
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Orthopedicjobs is seeking a Quality Assurance Engineer to develop and implement methods for process control and product testing within a hybrid work environment. The ideal candidate should have a background in mechanical or biomedical engineering, with 2-6 years of experience in design quality assurance, specifically in the medical device sector.
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Skills & Requirements
Must-have
EUMDR requirements
ISO 13485
21 CFR 820
risk management
design verification and validation
Nice-to-have
detail-oriented process improvers
critical thinkers
self-directed imitators
goal-oriented developers
advocate for product excellence
Key Requirements
B.Tech in Mechanical Engineering / Biomedical
2-6 years experience
2+ years experience in Design Quality Assurance (medical devices)
In-depth knowledge of EUMDR requirements
Excellent understanding of Quality Management Systems