Complaints Specialist • Location: Skaneateles, NY (Hybrid) • Type: W2 contract (NO C2C OR THIRD PARTY) • Length: Until 3/2026 (Contract extension expectation) • Pay Rate - $30 - $33 hourly depending on experience • Work Authorization - Must be able to work in the U.S. with approved authorization status.
What You'll Do:
This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint.
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis.
Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.
Education/Experience:
Bachelor's degree
Important information:
To be immediately considered, please send an updated version of your resume to Danh704@kellyservices.com
*** (Kelly does not expense relocation/interview costs) **
In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect: • Competitive pay • Paid holidays • Year-end bonus program • Recognition and incentive programs