Quality Engineer 3 - Medical Devices II & III

Please contact Abdul on "" OR email me at ""

Description:The Quality Engineer Consultant will join the Quality Engineering team and will be responsible for providing hands-on and strategic support in overseeing microsphere manufacturing projects for medical device/diagnostic products. This individual will be responsible for authoring, reviewing, approving, and modifying quality and manufacturing documentation, specifically for the equipment qualification, and equipment/process/test method validation protocols. This individual will also be drafting and updating PFMEA documentation and working on CAPA and nonconformance issues.

Required Experience:• 5+ years working with FDA regulated medical device quality systems• Minimum BS in engineering or similar scientific discipline• Med Device Class II and or III device experience (ISO 13485, CFR 820)• Quality and Manufacturing Document Authoring, modification, and review• Process Validation• Equipment Qualification• IQOQPQ• Document drafting, review, approval• Validation/Qualification protocol/report drafting, review, approval• Risk management w/ in med device industry• PFMEA drafting/updating• CAPA and root cause analysis experience• Experience with Engineering Change Procedures

Preferred Experience:• Test method experience• Experience in environments with chemistry and/or polymer manufacturing

Additional Skills / Knowledge• Computer and technology skillso MS Office Suiteo Adobeo Document management systemsPlease contact Abdul on "" OR email me at ""