Quality Assurance and Regulatory Affairs
QMS & Supplier Quality Expert
Zealand Business College
Available for: Full time, part time, tasks
Trained lead auditor/internal auditor.
Quality system implementation.
Have held titles as QC team manager, Supplier Quality manager, QMS manager and Head of QA.
Holding these titles, the companies have gotten certified or re-certified according to ISO9001, ISO13485, MDSAP, GMP+ and FSSC22000.
Assisted consultant customer in achieving recertification according to ISO13485 and obtaining IVDR certification while she was interim QA Manager.
Extensive knowledge in:
ISO9001 (Lead Auditor)
Medical device regulation 2017/245 (Internal Auditor)
- In vitro diagnostic medical devices 2017/246
- FDA 21 CFR part 820
- SAP QM Key user
- Documentum Key user
- MS Office
Helps to create team spirit.
Appreciates presence and equality.
Looks at the company with a holistic view, as all joints are needed to make the wheels turn.
In her spare time she spends time with family and friends, walks her two dogs, rides her bike or enjoy the family house in Sweden.