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Quality Assurance Specialist - Medical Device

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Quality Assurance Specialist - Medical Device

Regen Lab SA in Mont-sur-Lausanne is a leader in modern regenerative medicine based on autologous treatments of high quality standards and safety for patients.


We are looking for a multitask Quality Assurance Specialist to reinforce our QA/RA team.


Roles & Responsibility


- Managing and Conducting internal audits (Self Inspections)
- Interaction with regulatory authorities for change notifications
- Managing collaborator qualification
- Participating to sotware validation (FDA 21 CFR part 11)
- Support audit readiness (ISO 13485-MDSAP)
- Be an active team member, promote quality initiatives
- Ensure continued aligment with Regulatory Affairs teams requirements and planning


Qualifications


- University degree in Quality, Engineering, Sciences or equivalent
- At least 2-3 years in QA environment with Medical Devices
- Strong knowledge on European and US regulations, guidelilnes and standards such as ISO 13485,
  EC  Directive 93/42/EEC, FDA 21 CFR part 11, etc.
- Broad working knowledge of QMS ISO 13485 regulations; understanding of medical device
   manufactoring process
- Ability to effectively work as part of a multidisciplinary, international team


Languages


- French and English (oral and written)


This position speaks to You, so send the complete dossier at career@regenlab.com

Kontaktperson

Website www.regenlab.com

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Geben Sie hier Ihre Bewertung für die Firma RegenLab SA ab!

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