An enthusiastic, innovative and results driven people manager with more than 10 years international experience in the medical device world and a passion for Quality and Education.
Customer Quality Manager OUS Brussels, Belgium
Since May 2013
Key Responsibilities: Post-market surveillance and Vigilance reporting for Europe, Middle East Africa and Asia Pacific countries. Managing a team of 5 Clinical Technical Engineers. Key Achievements: Significant reduction in complaint handling cycle times. Established European vigilance summary reporting for certain adverse events.
Senior Specialist Customer Education Brussels, Belgium
January 2011 --- November 2012
Develop Customer Educational Curriculum for Cardiac Resynchronization Therapy (Heart Failure Therapy).
Support of the “Interventional EP curriculum” and adapt to the customer needs.
Trainer Cardiac Rhythm Management Brussels, Belgium
February 2008 --- January 2011
Key responsibilities: Develop and deliver employee and customer training for cardiac pacing and cardiac resynchronization therapy. New product introduction trainings for commercial teams. Key Achievements: EHRA endorsement for employee courses.
Technical Service Coordinator Arnhem, Netherlands
January 2004 --- February 2008
World wide Question and Complaint handling for Vitatron products
Reporting trends and cycle time,
Develpment and updating of SOP's related to complaint handling according 21CFR820 and ISO 13485. Prepare for FDA and TUV audits.
Provide input for product development and enhancements.
Contributed to several “Innovation Teams” and develoment projects.
Deliver international product training for sales reps and customers
21 CFR Part 11Adverse Events (AE)CardiologyCoachingCompetitive AnalysisContinuous ImprovementContract negotiationCompliance with regulationsElectrocardiogram (ECG)Emergency medicineISO 13485Medical Devicespeople managementPharmacovigilancePresentation SkillsQuality Assurance (QA)Technical SupportTraining
Bachelor in Graduate Medical Nurse. from HRIBP in 1989
Training and Certification
Marketing and Sales Management. in 2013 Training
Lean Six Sigma Green Belt. (Theoretical part) in 2014 Certification