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, sterilizationRequirements:
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
