Quality Control Analyst (Complaints Specialist)
The Complaints Specialist will be responsible for supporting post-market complaint handling and report submissions, which may include non-conformance investigations, field actions, and generating complaint handling metrics. The Complaint Specialist will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing and closure. The Complaint Specialist will communicate with Quality, Manufacturing, Product Development, Service and other functional experts and engineers as needed to ensure clear understanding/investigation of applicable issues.
- Directly interface with PKI employees and customers for reporting of customer feedback (complaints and adverse events) per corporate and site policy.
- Process complaints in a thorough and timely manner through all phases: risk assessment, acceptance, remedy, investigation, escalation, and closure.
- Apply strong written and oral communication and interpersonal (listening) skills are required.
- Develop and maintain knowledge of PKI product technology and customer applications; electro-mechanical technologies and associated manufacturing and service processes.
- Maintain current knowledge of applicable complaint handling standards and regulations; consider innovative solutions to meet changing standards and/or regulatory practice.
- Provide guidance and direction to peers; serve as expert in complaint handling process as implemented across IT systems.
- Prepare periodic complaint data/trend reports for management review or other business unit or site monitoring activity.
- Work independently and prioritize with little supervision; excellent process organization and time management.
- Support internal and external audits as needed.
- Other duties and responsibilities as may be assigned