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.
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
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