The Sr. Quality Engineer works closely with Manufacturing, Engineering, R&D, and Regulatory Affairs to ensure compliance with quality system requirements and lead process/product validation activities
Job Summary
The Sr. Quality Engineer works closely with Manufacturing, Engineering, R&D, and Regulatory Affairs to ensure compliance with quality system requirements and lead process/product validation activities.
This role involves ownership of major quality system investigations, audits, and providing leadership and mentorship to lower-level engineering positions.
Abbott offers career development opportunities with an international company recognized globally as a great place to work and values diversity and inclusion.
Matching Summary
The Sr. Quality Engineer works closely with Manufacturing, Engineering, R&D, and Regulatory Affairs to ensure compliance with quality system requirements and lead process/product validation activities.
Skills & Requirements
Must-have
Quality system compliance
Process and product validation
CAPA and audit management
Statistical data analysis
Risk management and FMEA
Mentorship of engineering staff
Quality investigations ownership
Nice-to-have
Project management experience
Advanced English communication
Cross-departmental collaboration
Technical writing skills
Use of SAP software
Experience with microbiology monitoring
Key Requirements
3-5 years quality engineering experience
Bachelor’s or Master’s degree in Engineering or related STEM field
Experience in medical device or pharmaceutical quality