The role involves leading complex Corrective and Preventive Action (CAPA) investigations from issue identification to closure while ensuring regulatory compliance
Job Summary
The role involves leading complex Corrective and Preventive Action (CAPA) investigations from issue identification to closure while ensuring regulatory compliance.
Candidates will partner cross-functionally with Quality, Engineering, Manufacturing, Service, and Commercial teams to ensure timely execution of CAPA actions.
Philips is a health technology company dedicated to improving lives by ensuring access to quality healthcare for everyone everywhere.
Matching Summary
Match Score: 85
The role involves leading complex Corrective and Preventive Action (CAPA) investigations from issue identification to closure while ensuring regulatory compliance.
Skills & Requirements
Must-have
5+ years FDA regulated manufacturing experience
End-to-end CAPA process expertise
Root cause analysis using 5 Whys and Ishikawa
Knowledge of 21 CFR Parts 803, 806, 820
ISO13485 and EUMDR regulatory standards
Cross-functional team collaboration skills
Nice-to-have
Proactive compliance intervention capabilities
Mentoring and training teams on QMS
Advanced English communication skills
Statistical analysis for quality data
Continuous improvement mindset
Key Requirements
Minimum 5+ years in FDA regulated environments
Bachelor's Degree in Engineering or Sciences
Strong understanding of global medical device regulations
Ability to commute to Alajuela, Costa Rica 3 days/week