Role (among others):
- Ongoing maintenance of the quality system in the company.
- Handling customer complaints and nonconforming products, leading quality investigations, finding root cause, defining corrective and preventive actions.
- Support for quality issues in production by subcontractors.
- Writing / updating quality procedures, protocols and reports, documentation control.
- Internal quality audits, employees training on quality issues.
Requirements:
Experience of at least 3 years in the field of quality.
Experience and knowledge of ISO13485 standard
Experience in writing procedures and reports
High level English
Advantage:
Relevant education (Degree, Quality, Biomedicine, etc.)
Experience in external quality assessments of certification bodies
Familiarity with MDSAP, 21CFR 820, MDR
Validations of processes, risk survey, clean room, sterilization
