The Senior Associate Quality Engineer is responsible for advanced quality oversight across daily operations, incident management, investigations, and client-facing quality activities. This position partners with Operations, Account Management, and internal/external customers to act as a quality liaison to drive risk-based decision making, identifies emerging quality risks, and contributes to continuous improvement initiatives to strengthen compliance and process efficiency.
Key Responsibilities
Responsible for the oversight of the Corrective Action/Preventive Action (“CAPA”) program for their area of responsibility including but not limited to review all non-conformances to ensure they are documented, review all corrective/preventive actions for completeness, and execute effectiveness checks when required.
Assist with Non-conformance Investigations assigned to Quality Assurance, as needed. Responsible for ensuring timely closure of CAPA record...