*Kindly reply to : narayan.chau...@avanceservices.us <narayan.chau...@avanceservices.us>*
*Need Medical devices tester in NY - 6+ Months contract!* *Position : Medical Devices Tester* *Location : Rochester, NY* *Location : 6+ Months* *Description:* Maintain DMR’s to current requirements. Documentation of Risk Management requirements per ISO 14971:2012. Review/approve GMP documents (e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates (DCO’s, QCR’s) Support post launch design changes and product updates as required. *Scope Of Position:* Sales volume responsibility Budget responsibility Size of Team Sites Support maintenance of Design and DMR files for Contract Manufactured Medical Devices. Additionally the role will support marketed product changes and updates (MOB). The role includes working with multidisciplinary teams to ensure medical device design files are compliant with Design Control Requirements. Provide Quality Assurance support to contract manufacturing sites as needed. *KEY RELATIONSHIPS:* (e.g. internal customers/business partners, external customers/partners) R&D Project Management Regulatory Affairs Design Quality Supplier Quality External Manufacturers *EXPERIENCE* (e.g. health care industry, multinational company, number of years, what level/types of roles, etc) Three years’ experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment. Specific experience desired is as follows: Three years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices. One year utilizing corrective and preventive action (CAPA) system that is in compliance with US federal and international regulatory standards relating to medical devices. One year Complaint management, complaint review and corrective action. One year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not, One year risk analysis experience *-- * *Best Regards,* *Narayan Chauhan* *Talent Acquisition* *+1 732 276 9933 Ext : 251* *narayan.chau...@avanceservices.us <narayan.chau...@avanceservices.us>* -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-basis+unsubscr...@googlegroups.com. To post to this group, send email to sap-basis@googlegroups.com. Visit this group at https://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.
