3002566659-2 Apply for this job now Job Description Abbott Laboratories seeks a Quality Engineer to ensure the safety, reliability, and compliance of biotech and pharmaceutical products. In this role, you will develop and execute validation and test protocols, lead root cause analysis and CAPA, and maintain strict compliance with FDA, ISO, and GMP requirements. You'll partner closely with R D, manufacturing, and regulatory teams to embed quality in new product development and continuous improvement. Abbott offers global impact, career growth, and a collaborative, inclusive culture dedicated to advancing life-changing healthcare solutions. Responsibilities Develop and execute quality plans, validation protocols, and test methods for biotech and pharmaceutical products Perform root cause analysis and drive corrective and preventive actions (CAPA) to resolve quality issues Ensure compliance with FDA, ISO, and relevant regulatory and quality standards across products and processes Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement Collaborate with R D, manufacturing, and regulatory teams to integrate quality into new product development Support audits, inspections, and documentation for quality system compliance Author and maintain SOPs, technical reports, and quality records in accordance with GMP requirements Provide quality engineering support for process changes, equipment qualification, and risk management activities Required Skills Quality engineering Design controls Root cause analysis CAPA management Risk management (FMEA) Validation and verification GMP compliance FDA and