Interface with appropriate internal/external groups to gather necessary information to conduct timely complaint investigations. Execute risk assessment as needed during the course of the complaint investigation. Possess and utilize knowledge of formal problem solving tools and appropriate application of those tools. Perform root cause analysis as necessary. Independently conduct complaint investigations following Client’s relevant Quality System Procedures. Remediate complaint files as necessary. Possess and utilize excellent technical writing skills. Possess and utilize extensive working knowledge of risk management per ISO 13485, and 21 CFR 820.198 and 820.200. Experience working in and executing complaint investigations as detailed above. Investigator will support Client’s Investigations and Quality System Remediation efforts as directed by Client. Such support will include, but not be limited to (i) Investigations clearly documented with appropriate objective evidence; (ii) Investigation executed using appropriate formal problem solving tools commensurate with the risk of the issue.; (iii) instruction/education/training of Client personnel on Investigations; and (v) other activities as may be directed by Client and reasonably related to Investigations. Write timely, accurate and defendable complaint investigations – complete investigation within 60 days and investigation reviews(as necessary) within 30 days

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