This job has expired.
Location: Solon, OH
Salary: $55.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Biomechanical Engineering for an 18 month contract.
Quality Engineering with focus on Design Improvements
• Develop knowledge with the following regulations and standards:
o 21 CFR Part 820 - Medical Device Quality System Regulations (QSR)
o ISO 13485:2016 Medical devices - Quality management systems
o EN ISO 11135-1:2007 - Sterilization of healthcare products - Ethylene Oxide
o EU Medical Device Regulation
• Assist in Non-Conforming material resolution including root cause investigation and communication with suppliers.
• Assist in Corrective and preventative action (CAPA) including root cause investigation and effectiveness check.
• Perform Design Verification/Validation
• Support supplier issue resolution.
• Perform data analysis/trending as requested and prepare quality improvement presentations.
o Local Candidates only 100% on-site, open to Hybrid role.
o Travel required? No
o Years of experience? Degree plus 2 years
o Software skills? • CAD, highly preferred
o Medical device background required? No, highly preferred.
o Any particular industries or Job Titles? QA or Manufacturing Engineer
Day to Day:
o Design change.
o Verification and validation.
o Document updates.
o Drawing updates.
o Data analysis.
Contact: eronan@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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