JOB SUMMARY:

The Senior (Sr.) Quality Control (QC) Analyst performs routine and non-routine quality control testing of raw materials, in process materials, and finished medical device products within a regulated environment in compliance with the Quality Management System (QMS). The role supports method validation and transfer, stability programs, investigations, and CAPA activities, contributes to data review and trending, and provides guidance to junior QC staff while ensuring laboratory and equipment compliance. This roles reports to the QC Supervisor and acts as the delegate for the Supervisor in their absence.

MAJOR RESPONSIBILITIES:

QC Testing and Documentation

• Perform routine and non-routine QC testing in accordance with approved methods, specifications, and schedules.
• Ensure QC activities comply with ISO 13485, GMP, GLP, and internal QMS requirements.
• Review laboratory data, calculations...