Work Experience
November 2021 - Present
October 2020 - October 2021
(1 yr 1 mo)
Januar 2020 - September 2020
(9 mo)
December 2016 - December 2019
(3 yrs 1 mo)
June 2014 - November 2016
(2 yrs 6 mo)
January 2008 - May 2014
(6 yrs 5 mos)
July 2003 - December 2007
(4 yrs 6 mos)
Metis Compliance
Owner and Freelance Consultant
Agilent Technologies
Manager - Quality Assurance - Process Engineering
Building a strong team in a changing organization.
- Major organizational change.
- Team grew from 4 to 11 members.
- Exemplary retention rate.
Process/method and software validations.
Equipment Qualification.
Process Monitoring.
CAPA activities.
Change management (daily operations).
Recall Lead investigator.
WSAudiology
Manager - System Integration Test
Design V&V activities prior to release of new software or hardware.
User testing (non-automated).
Agilent Technologies
QA Validation Specialist
Process Validation
Process Monitoring
(Test) Method Validation
Root Cause Investigations and CAPA process
Internal training in Validation disciplines.
Cook Medical Europe
Manager, Test & validation
Manager of a team of 11 employees.
Responsible for non-clinical test.
Responsible for the validation programme.
Coaching of employees in validation methodology and statistical analysis.
Supervisor, Test & Validation
Manager of a team of 6 employees.
Remediation activities (post FDA warning letter).
Implementation of Master Validation Plan (MVP).
Implementation of global non-clinical testing procedure.
Unomedical (Convatec B2B)
Specialist, Design for Six Sigma and QFD
Internal education in statistical methods for use in product development, validation and optimization of products, processes and test methods.
Mentoring/sparring in above mentioned disciplines as well as other ad hoc tasks.
Off-site project management.
Responsible for implementation of MSA (Measurement Systems Analysis).
Statistical tolerancing.
Design and Development Engineer
Core team member in product development projects for the medical industry (devices) under ISO 13485.
Designing of parts/components in plastics, mould qualification, process validation and part verification.
Practical experience with test method validation and design of experiments (DoE).
Internal mentoring/sparring and education in statistical methods for use in product development, validation and optimization of products, processes and test methods.
DBI Plastics A/S
Project manager
Development of solutions for the automotive business, handling all aspects from the initial voice of customer to the introduction of the final product and documentation package. Customers counted most major automotive companies in Europe, but also companies from the construction business and other businesses ranked amongst the customers.
Partook in preparing the company for ISO/TS 16949 certification as the first company in the segment worldwide.