This position supports Abbott's Electrophysiology division in advancing heart disease treatment through breakthrough medical technologies
Job Summary
This position supports Abbott's Electrophysiology division in advancing heart disease treatment through breakthrough medical technologies.
The role involves verifying adherence to quality systems, conducting risk analyses, and leading process validation activities like IQ, OQ, and PQ.
Candidates will work closely with Manufacturing, Engineering, and Regulatory Affairs to ensure compliance with Key Performance Indicators and regulatory standards.
Matching Summary
This position supports Abbott's Electrophysiology division in advancing heart disease treatment through breakthrough medical technologies.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Bachelor Degree in STEM field
Knowledge of FDA GMP ISO 13485 regulations
Proficiency in statistical data analysis tools
Experience with Root Cause Analysis and Six Sigma
Ability to conduct CAPA and NCMR investigations
Nice-to-have
Prior medical device industry experience
Previous Quality Engineering experience
Experience with SAP ERP System
Intermediate English command
Mentorship capability for junior engineers
Key Requirements
0-3 years of professional experience
Bachelor Degree in Science, Technology, Engineering, or Math
Knowledge of control of nonconforming material and corrective actions