QM Documentation Specialist Contract (m/w/d)
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4500 Solothurn, Schweiz |
Temporary Employment
Job title: QM Documentation Specialist Contract (m/w/d)
Industry: MedizintechnikSkills: ISO 13485, SOP, Documentation
Start of project: ASAP
Duration of the project : 9 Months
Project volume: 1512 Stunde(n)
Location: Solothurn und Umgebung
Tasks:
- Develop, write, and revise SOPs based on intricate processes and documentation requirements.
- And also rewrite documents based on existing content using international industry standards and practice to fit the corporate requirements with also minimal input from in-house SMEs
- Ensure all documentation aligns with the latest industry standards and regulatory requirements.
- Adapt documentation processes to meet the requirements of various international regulatory bodies.
Qualifications:
- Have a good knowledge of and ensure compliance with applicable standards and norms such as ISO 13485:2016, US FDA-21 CFR 820, EU MDR (2017/745), and Medical Device Single Audit Program (MDSAP).
- Utilize SAP Pronovia for documentation management (knowledge of SAP Pronovia is a plus).
- Stay current with industry best practices and technological advancements in documentation processes.
Referenznummer: 14809
Branche: Medizintechnik
Beginn des Projekts: ASAP
Dauer: 9 Months
Anstellungsart: Temporary Employment
Kontakt
Minette Potger