Erika has over twenty years of experience in Quality Management and (Internal) Auditing field. Within Qserve, Erika is responsible for the internal Quality Management System (QMS), which is certified according to ISO 9001: 2015. She takes the lead in further developing and strengthening our quality processes and -system.
The key expertise areas of Erika
- Understanding of ISO 9001:2015 and ISO 13485:2016 compliance. Responsible for daily maintenance of the quality management system.
- Change management including training staff on changes, new procedures and templates.
- Coordinating and performing internal audits, making/executing CAPA plans for improvement.
- Critically reviewing internal processes and advising and assisting the process owners in improvements and optimizations regarding quality, risk control and efficiency.
- Monitoring incidents, complaints and/or events which will affect our critical processes, analyzing and reporting to management.
- Coordinating management reviews and audits from our certification body and clients. Being involved in and/or coordinating internal improvement projects.
- Supporting new service developments and maintaining our internal controlled tools for execution of our services.
- Maintaining and continuously improving our knowledge management infrastructure in a SharePoint environment.
- Document management and ensuring that all users are informed and comply with the guidelines and agreements that have been made for the use of our system.
- Promoting the use and benefits of harmonization and sharing of our knowledge and working methods through our intranet platform, soliciting new ideas and including people where possible.
Erika about working at Qserve
‘’Qserve has a worldwide scope of activities and has a very inspiring and dynamic environment. It is great to work with a lot of specialists from different cultures within one company, to learn from each other and together to continuously improve our business processes”.
Prior to joining Qserve as Quality Manager, Erika held a role as Quality Manager at a Dutch production company, where she was responsible for Quality Management and for implementing an integrated QMS andISO 9001, ISO 14001 and Ohsas 18001Certification.
Prior to that, Erika worked in the Pharmaceutical Industry (MSD, former Organon) where she had different roles within Global Market Access, and she worked for its parent company Akzo Nobel as Internal Auditor. She started her career at Notified Body SGS where she worked as Lead auditor ISO 9001 for four years.
Erika has a Bachelor degree Business Economics at the Erasmus University in Rotterdam with specialism in quality & internal organization - process management.