Job Description Summary

As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position
actively participates in quality guidance, product resolution decisions and statistical problem-solving techniques for released medical devices and project teams for process improvement and continuous improvement activities.

Job Description

P3-14175

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.
• Works under general direction
• Independently determines and develops approach to solutions.
• Designs and performs development working independently within defined parameters with minimal supervision required
• May provide guidance and work direction to lower-level System specialists
• Able to manage the end-to-end process of customer complaints including review and maintenance of complaint files and executive summary of investigation preformed.
• Escalation of complaints and completion of elements of investigations of device failures of complaint investigations as required. This may include collaboration with R&D, Medical affairs, Unit Quality and other teams as indicated.
• Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures and collaboration with manufacturing facilities.

• Work with Regional Complaint Centers to resolve and address complaint handling issues. Ensure intake of complaint information is accurate and complete. Raise queries to regional complaint centers to obtain additional information on the specifics of the failure of the device. Can entail direct communication with the customer as the subject matter expert of the device to aid in failure specifics Via phone call.

• Utilization of database systems used to process complaints, create and measure Quality metrics and manage electronic MDR supplemental reports to the FDA for USA medical device reporting regulations.
• 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. Including the oversite and participation in peer review of product complaint files for completeness and accuracy.
• May File MedWatch reports after Leader reviews and approves.
• Participate in audits when required
• Participate in SCAR activities when required
• Facilitate meetings when collaboration with multidisciplinary teams is needed to bring a complaint to resolution with the customer. I.e. Medical affairs, regional complaint centers, R&D, sourcing team etc.