Quality Engineer (Validation)

Key Responsibilities

• Develop, execute, and review validation protocols and related documentation according to Abbott procedures.
• Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.
• Manage site Validation Review processes (VRB), including reviewing and approving site change controls and validation change requests.
• Perform root cause analysis and identify corrective and preventive actions for quality events.
• Support the resolution of validation events and escalate concerns in a timely manner.
• Support equipment and process walkdowns.
• Provide weekly, monthly, and quarterly reporting as required for the business area.
• Support Monthly and Quarterly Quality Management Review (QMR) and Business Management Review (BMR).
• Coordinate and support periodic plant stoppage activities related to validation and change control functions.
• Develop and execute business area improvement projects.