QA Engineer

• Ensure compliance with industrial standards and regulatory requirements
• Create and improve hardware department procedures and work instructions within the framework of ISO 13485
• Collaborate on in-house and subcontracted hardware development for new products
• Maintain associated technical product documentation
• Coordinate cross-functional work performed by internal and external stakeholders/suppliers
• Track project progress in terms of quality and timelines while ensuring expected performance targets are met
• Contribute to the preparation of quality/regulatory documents such as: biological evaluations, technical files and risk analyses; develop test plans; create and modify product labeling
• Write quality control reports
• Conduct internal and supplier audits
• Monitor actions related to non-conformities
• Participate in change integration

Hardware Quality Engineer

Software Tester

Quality Assurance Officer