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Investigator - Complaint Systems

Company: Modis
Location: Largo
Posted on: June 8, 2019

Job Description:

An Investigator, Complaint Systems job in Largo, FL or Utica, NY?is available through Modis Engineering. You will review, investigate and process domestic and international complaints for Medical Device Reporting (MDR) and International (Vigilance) Device reporting requirements based on FDA Regulations, and International [Medical Device Directive (MDD)] Device Reporting requirements. This is a six-month contract opportunity, with possible perm placement.?The salary is between $25.00 to $26.44 per hour.?Local candidate only as relocation assistance is not available. Per client contract requirements, US citizens and Green card holders only will be considered.?Investigator, Complaint Systems job responsibilities include:????????????? Triage, review and manage the movement of all credit returns/devices related to complaints as needed for further review, analysis and/or root cause investigation.????????????? Initiate the investigation process by gathering sufficient documentation for risk assessments and investigations.????????????? Identify and notify appropriate personnel for conducting root cause investigation.????????????? Assist in determining the need for corrective/preventive actions or other required actions.????????????? Provide technical support to investigation team and/or product design teams.????????????? Maintain high level knowledge of products, service/repair processes and manufacturing processes.????????????? Participate in internal/external audits, corrective/preventive action and product team meetings as required.????????????? Maintain working knowledge of domestic and international regulations or standards related to Quality System Regulations (QSR), International Standards Organization (ISO), Medical Device Directives (MDD) and other international country regulations and medical device/adverse event reporting requirements.????????????? Perform training and instructional guidance for employees in complaint system handling, QSRs, ISO Quality Standards and other topics as required.????????????? Ensure accurate complaint/return data integrity to facilitate trending of complaints and service issues.??QUALIFICATIONS:????????????? BS degree in engineering, chemistry, sciences or equivalent experience in quality or regulatory industry.????????????? Minimum of two years experience in pharmaceutical, medical device, chemical or related industry experience in production, quality or regulatory compliance.????????????? Basic knowledge of GMP/QSR regulations and knowledge of MDR reporting requirement desirable. Strong working knowledge of QSRs, European Union Directives, ISO 13485 and related International Medical Device regulations preferred.?If you are interested in this Investigator, Complaint Systems job in Utica, NY or Largo, FL then please click APPLY NOW.?Equal Opportunity Employer Minorities/Women/Veterans/Disabled--

Keywords: Modis, Largo , Investigator - Complaint Systems, Other , Largo, Florida

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