Hi, My Name is Paul I am looking for Risk Analyst at Warsaw, IN. If interested please reply me back with your updated resume along with your hr/rate expectation. Analsyt ( risk management) Location Warsaw, IN, USA Start date Immediate Deputation period 12 months Rate-$50 Job Description: PME Activities 1) Investigate product complaint issues and provide disposition 2) Create/Update Risk Management File of existing products according to ISO 14971. 3) Perform corrective and preventive action (CAPA) due to various issues such as product complaints, risk management file update, manufacturing/quality issues, etc 4) Initiate and complete change (design and other necessary change) following change control process 5) Disposition of non-conforming parts (NCR) 6) Executing product improvement/line extension projects (concept through launch including driving the project) following 21 CFR 820 7) Support various external projects such as Regulatory (ad-hoc projects like existing product registration in a new region, updating technical file or design dossier due to changing regulatory requirements in Europe or other regions), manufacturing (manufacturing process change like sterilization process change or diffusion bonding process change requiring a new 510k submission or a PMA supplement), quality (FDA/BSi audit finding issue) 8) Support Sourcing transfer activities of existing products from an existing vendor to a new vendor. This will include supporting all the validation and verification activities. 9) Mentoring new engineers NPD Activities 1) Create new concept designs 2) Participate in validation activities (Cadaver study, Saw Bone testing, etc) 3) Participate in the test protocol activities and execution of testing 4) Perform Functional Relationship Analysis activities 5) Perform risk management activities Thank you & Regards, Paul IDC Technologies, Inc. 1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA, 95035 Office: 408-852-7191 Fax: 408-608-6088 Email to: paul <mailto:e...@idctechnologies.com> @idctechnologies.com Web: <blocked::http://www.idctechnologies.com/> www.idctechnologies.com Yahoo IM - paultcs...@yahoo.com GTalk - paultcs...@gmail.com cid:image001.png@01CBEADA.88654760 -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To post to this group, send email to us_itgroups@googlegroups.com. To unsubscribe from this group, send email to us_itgroups+unsubscr...@googlegroups.com. For more options, visit this group at http://groups.google.com/group/us_itgroups?hl=en.
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