Complaint Specialist

Kelly Services is actively seeking a Complaint Specialist - Medical Device for a long term (1+ year) hybrid engagement with one of our global clients located in Horsham, PA.

Pay rate: Open + Benefits & PTO

Hybrid role

Responsibilities:

• Perform end-to-end complaint handling activities, including but not limited to Intake, triaging, recovery of field samples for evaluation, perform due diligence with complainant/intake centers/LOCs, trend analysis, defect coding, risk criticality assessment, and ensuring accurate/holistic investigation.
• Ensure that uniform and timely management of complaint records from receipt to closure, and investigations are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
• Allocate and balance competing priorities in driving business results.
• Provide support for the PQV group with the development, revision and / or maintenance of applicable documents WI/Job Aids/SOPs.
• Communicate directly with customers patients, pharmacies, healthcare providers, etc. to obtain follow-up information for reported complaints.
• Perform other project / department duties as assigned.

Requirements:

• Bachelor's degree preferred
• 2-5 years of related experience including Quality Assurance and/or Quality Control in a high-volume complaint handling unit with medical device or combination product reporting responsibilities preferred.
• International medical device regulatory reporting expertise is desired.