Need GCS or CITIZENS Position: Quality Assurance Manager Location: Gilroy, CA Duration: 6month c2h
Summary: Responsible for insuring the overall quality of products and service, compliance with FDA requirements. Manage and coordinate any special projects as needed. Essential Functions & Responsibilities: Quality Assurance: • Coordinate the implementation of quality procedures. • Interface with vendors to resolve quality challenges. • Write procedures for quality policies, including receiving inspection, packaging specifications and vendor specifications. • Supervise the testing of Theraputty, Elastomer and splinting material. • Research and resolve customer products and complaints. Supervision: • Interface with the Customer Service Manager. • Test new products. • Manage and coordinate any special projects assigned by the COO. Regulatory Affairs: • Implement and monitor good manufacturing practices. • Act as liaison to both the FDA and the California Dept. of Health. • Responsible for internal audits required by the FDA and California Dept. of Health. • Develop and provide information as it pertains to product performance, adherence to government standards, and product statistics. This includes, but not limited Material Safety Data Sheets (MSDS), Good Manufacturing Practices, Medical Device Directive and Hazardous Materials Awareness, Harmonized Tariff Codes and FDA Product Listings. • Communicate product quality concerns to management. • Maintaining document control systems and quality system files. • Maintain All SOPS-Maintain training records • Report on Open CAPAS Projects and Task: 1.) FDA • Develop & train on DHR • Management Meeting • Interval Audits • MOR Reporting • Complaint handling & trend reporting • FDA Classification on all new items • Inspection SOPS-Development of new/training on existing • Annual device listing update • Health Canada Registration/communication • CAPA Reporting • 483 response management 2.) CE • Create specs • Revise and update tech packs • Update tech files • Language update on IFU’S 3.) ISO/3485 • Manage quality manual creation/EDT Minimum Requirements: • BA/BS in Engineering field and at least (4) years QA related work experience in the medical device/ pharmaceutical fields • Experience with Domestic and International regulations as they regulate to Medical Devices and Manufacturing (FDA & CE) • Computer skills (All office programs especially excel) • Excellent written and verbal communication skills. Experience: • Class 1, 11, 111 Medical Devices • RX, Cosmetic OTC • 510 R Updates *Ashutosh Singh* Talent Acquisition Manager 614-662-1007 ashut...@technocraftsol.com *ashu.technocr...@yahoo.in <ashu.technocr...@yahoo.in>* ashu.technocr...@gmail.com -- You received this message because you are subscribed to the Google Groups "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
