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• As a Quality Specialist in Scope Fluidics you will be responsible for supporting and maintaining the Quality Management System (QMS) in compliance with ISO 13485. Your role includes document control, process improvements, internal and supplier audits, and ensuring regulatory requirements are met throughout the product lifecycle. You will collaborate with cross-functional teams to drive quality initiatives, support CAPA activities, and contribute to continuous improvement of quality and compliance across the organization,
• • Supervision of system documentation (procedures, records).
• • Oversight of process updates, support for other departments in creating procedures.
• • Oversight of the audit schedule, conducting internal and supplier audits.
• • Participation in external audits.
• • Ongoing support for the QARA department.
• • Training other departments on new processes and standards.

Nasze wymagania

• Experience with ISO13485 standard
• Auditing experience
• Experience with IVDR/MDR (nice to have)​
• Experience with FDA (nice to have)
• ISO13485 auditor training certificate (nice to have)​

To oferujemy

• Hybrid work model

• Flexible working hours

• A chance to work on impactful and meaningful scientific projects

• Learning opportunities within a skilled research team