Quality Technician
CurrentCertified ISO13485 Lead auditor – Training provided by QCS International (CQI & IRCA approved).• Complaint handling, tracking, investigating & reports• CDT&R (Customer defect tracking & resolution)• Change control, review & amend procedures & documents • Continuous improvement• Customer/vendor qualification questionnaires• NCR and process control • Deadline management • Problem Solving – Lead and support RCCMs • Smart solve (Pilgrim) database input • Risk assessment & CCRC closeout• Global communication with 3rd party suppliers – USA, Mexico, Puerto Rico, China, Japan, Morocco, India & Monaco• Global communication with customers • Support audits to ISO13485, ISO9001, ISO14001, ISO22301 & FDA CFR21 Part 820 & Part 11• Lead audits to ISO13485, ISO9001, ISO14001, ISO22301 & FDA CFR21 Part 820 & Part 11