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 Job #03228 Email this job to a friend
About our client
Our client is one of the world's leading medical device providers. They are a highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company, which offers a great corporate culture and is focused on the long-term development of its employees.
Position Location
Quality Engineer Allendale, New Jersey
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Coordinate and/or perform complaint investigation as well as ensure related follow-up activities and document investigation findings/results
2) Perform internal audits
3) Provide support/perform failure evaluation on returned products
4) Ensure effective CAPA is taken to help prevent recurrence
5) Prepare reports and facilitate meetings to resolve customer complaints
6) Make periodic trending reports
7) Monitor customer complaints and provide immediate feedback to concerned personnel when a critical issue is detected
8) Ensure complaint closure time is within the company target
9) Provide general support to Quality Assurance Team in day-to-day activities
Requirements
1) Bachelor's Degree in Science/Engineering
2) Minimum 3 years of experience in the medical device industry
3) Knowledge of related industry standards, FDA and International Medical Device regulations (CFR 820 QSR, ISO 13485, ISO 9001 and European Medical Device Directive)
4) Excellent communication skills (written and oral)
5) Ability to resolve problems

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