To support the development, maintenance and adherence to the Softhale Quality Management System (QMS) in Softhale.
Document Control:
- Maintenance of controlled document standards, issue, and archive
- Maintenance of SOP training system including auditing of Training Files
Compliance Monitoring:
- Maintenance and follow-up of CAPA and Change Control systems
- Maintenance, compilation, and analysis of Quality metrics
- Preparation of materials for Quality System Reviews
Supporting work in the following area:
- Maintenance of company certifications (ISO 13485)
- QA review of project documents and records as necessary
- QA review of vendor company quality documents and records as necessary
- Preparation and reporting of internal and external audits
- Continuous Improvement (CI) of the documents and systems of the QMS
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