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Quality Analyst - Complaints Management job in Vernon Hills at millenniumsoft

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Quality Analyst - Complaints Management at millenniumsoft

Quality Analyst - Complaints Management

millenniumsoft Vernon Hills, IL Full-Time

Position : Quality Analyst - Complaints Management

Location : Vernon Hills, IL

Duration : 9 Months contract

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description:

  • Consistent application of Quality system standards to assigned Quality system area.
  • Develops solutions to routine assigned activities of moderate scope & complexity.
  • Follows applicable Company / Unit procedures and may make updates to procedures and policies
  • Works within and across functions for assigned Quality systems
  • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
  • Accountable for setting own work direction and completing work tasks.
  • Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer.
  • Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible.
  • Recommend corrective and/or preventative action(s) related to customer complaint issues.
  • Identify and monitor patterns and trends in complaint issues related to assigned product groups.
  • Provide a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions and recommendations.
  • Develop test protocols and reports where required.
  • Escalate high priority issues as well as identified business risks to the appropriate management level.
  • Escalation of complaints and assist in complaint investigations as required.
  • Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures.
  • Development of Complaint Closure Letters as required.
  • Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports.
  • Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements.
  • Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements.
  • Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.
  • Files MedWatch reports after Leader reviews and approves if applicable.
  • Perform other duties as assigned.

Additional Responsibilities:

  • Contributes to the completion of specific programs and projects.
  • Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints.
  • Contribute to the business-wide Quality strategy and objectives.
  • Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting
  • Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
  • Represent client MDS on cross-business teams related to Quality Systems.

Qualifications:

  • Consistent application of Quality system standards to assigned Quality system area.
  • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
  • Requires a minimum of a Bachelors Degree
  • Prefer Clinical, Science or Engineering
  • Prefer a minimum 2-3 years relevant experience or a combination of equivalent education and relevant experience.
  • Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.

Recommended Skills

  • Adaptability
  • Clinical Works
  • Communication
  • Corrective And Preventive Action (Capa)
  • Databases
  • Engineering
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