Quality Engineer (Validation)

Ensure that change control and validation activities are executed in a timely manner.

• Comply to all policies and standards.
• Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies.
• Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.
• Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests.
• Perform root cause analysis and identify corrective and preventive actions in addressing quality events
• Support resolution of validation events and elevate concerns in a timely manner.
• Support in equipment and process walkdowns
• Weekly, Monthly and Quarterly reporting as required for own business area
• Support Monthly and Quarterly Quality Management Revi...