• Nonconformance and CAPA management in certified Medical Device Company
• Certified Internal Auditor ISO 13485
• Support on Notified Body audits and Costumer audits
• Post market control of nonconforming products and Root Cause Investigations
• Extensive laboratory experience in ISO 13485 and FDA labs
• Technical documentation for clinical trial projects

Well structured, with a strategic approach on complicated tasks.
Strong coordination skills, with an eye for details.

Focused and goal-oriented mindset combined with a positive and holistic and inclusive approach, to ensure that chosen solutions include the best solution for stakeholders.

In her freetime, she is spending time with the family and working on her family farm, and breeding and training horses.

Over the last 16 years her main focus has been on measurement, analysis and improvement in various job roles.

Variation from documentation and validation of test methods in laboratories as well as product release, validation and recalibration of equipment and documentation for QMS and audits relating.

Over the last years the focus has transitioned to control of nonconforming products in relations to MDR, MDSAP and ISO 13485 with branches to design control, change control, risk management, design verification and revalidation and recalibration of machines and equipment.