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Quality Assurance Specialist

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

 

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