about the company.
this is a European medical device company whose core products are Class I and Class II medical devices.
about the team.
replacement, report to sales head
about the job.
• Handle customer complaints and technical inquiries professionally and efficiently
• Investigate product complaints and perform root cause analysis
...
• Document and track complaints in the quality management system
• Coordinate with cross-functional teams to implement corrective actions
• Prepare complaint investigation reports and regulatory submissions when required
• Analyze complaint trends and provide regular reports to management
• Support customer audits and regulatory inspections
skills and experience required.
• Bachelor's degree in Engineering, Biomedical Engineering, or related field
• 3+ years' experience in medical device industry
• Knowledge of EU MDR, ISO 13485, and CAPA processes
• Proficiency in quality tools (8D, FMEA, 5-Why, Ishikawa diagram)
• Strong problem-solving and analytical skills
• Excellent written and verbal communication skills in English
• Experience with quality management systems
• Ability to travel occasionally (10-20%)
