Complaints Management Specialist

Job Description

Key responsibilities will include:

• Handles activities and procedures associated with IDS product complaints.
• Supervises the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports.
• Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints.
• Supports Market Segment Teams.
• Utilizes the database systems used to process complaints and processes customer complaints.
• Mentorship and education regarding customer complaint processing, MDR’s, complaint report ability, and regulatory compliance.

About You

Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints.

• Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.
• Provides mentorship, review and generates MDR reports utilizing client procedures and FDA regulations.
• Contributes to the business-wide quality strategy and quality objectives.
• Maintains systems to supervise and facilitate the timely investigations and close out of open complaints.
• Ensures complaints are investigated and completed in a timely manner.
• Supervises and communicates significant complaint trends, adverse events and other pertinent reports.
• Provides and analyzes organizational quality metrics as required to assess the efficiency of quality system improvements.
• Provides internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.
• Interacts with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis.
• Ensures the customer complaint investigation, procedures, and activities follow applicable FDA and ISO requirements for complaint handling and adverse event reporting.
• Exhibits flexibility and resourcefulness by leading assignments in accordance with project priorities and by altering course of action when and where vital.
• Maintains ethical responsibility to maintain privacy and confidentiality of patient records and private information.
• Represents IDS on cross-business teams related to Quality Systems.
• Pairs with other quality professionals to address recurring issues identified throughout the organization.
• Provides Education: Provides on-going education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment.

Qualifications

• Basic understanding of regulatory standards.
• Experience in health care setting where client or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.
• Minimum of one (1) years’ experience in health care setting where client or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.
• Education: Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering subject area.