Quality Analyst - Complaints Management

Position:
Quality Analyst - Complaints Management

Location:
Vernon Hills, IL

Duration: 10+ Months Contract

Total Hours/week: 40.00

1st Shift

Client:
Medical Device Company

Job Category:
Quality

Level Of

Experience:

Seniority Level

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

No H1B’s

• 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 Med Watch reports after Leader reviews and approves if applicable.
• Perform other duties as assigned.

• 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 BD MDS on cross-business teams related to Quality Systems.

• 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 Track Wise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.