Quality Assurance and Regulatory Affairs
Consultant and Principal Advisor QA/RA
M.Sc. in Molecular Biomedicine
Available for: Part time, tasks
- ISO13485 Medical device lead auditor.
- QMS management: ISO13485, FDA 21 CFR part 820 and In vitro diagnostics and medical device regulations (MDR/IVDR).
- GMP and Quality Assurance (QA).
- CAPA and non-conformance handling.
- Process- and test method validation.
- Risk management.
- Supplier quality management.
- Quality Control (QC).
- Design control and transfer.
- Change control.
- Project management.
- People management.
Revised and optimized the entire QMS system under the merger between Widex and Sivantos Hearing Aids companies into WSAudiology and contributed greatly to the successful accomplishment as the first MDR certified company in the hearing aid industry. The new QMS ensured not only regulatory compliance but also the benefit from synergy effects which reduced costs and optimized the processes in the new global company with+10.000 employees worldwide.
Reduced the batch release lead time and backlog by 50% within3 months by implementing a shop floor system in collaboration with key stakeholders as production-and procurement teams including clear roles and responsibilities between the teams.
She is a highly skilled QA/RA consultant with five years’ experience in safety, quality and regulation of in vitro diagnostics and medical devices, with a background in research, shop floor management and business development.
She holds a unique profile, combining a strong process- and business-oriented mindset with solid QA/RA knowledge which enables her to successfully translate regulatory requirements and legislations into practical processes and simple procedures.
The key to her good results is her pragmatic approach, fast understanding of complex matters and engaging key stakeholders delivering lean but high-quality solutions.