Quality Assurance & Regulatory Affairs (QARA) Specialist at Quin

Quin, a dynamic healthtech company specializing in digitalizing patient inflow processes, is seeking a skilled and experienced Quality Assurance & Regulatory Affairs (QARA) Specialist. This role is crucial for strengthening the company's quality management systems and ensuring compliance with industry regulations and certifications. The QARA Specialist will work closely with management, product, tech, and medical specialists to maintain high standards of quality, security, and regulatory compliance.

Role Involves:

• Ensuring ongoing compliance with ISO 27001 and NEN 7510 standards
• Contributing to the development and implementation of the Quality Management System (QMS) for ISO 13485
• Leading or supporting CE marking activities
• Conducting internal quality audits and risk management activities
• Managing registrations and communications with competent authorities
• Handling non-conformities, customer complaints, and regulatory incidents

Requirements:

• Strong knowledge of quality management systems and industry standards
• Hands-on, proactive, and highly collaborative approach
• Comfortable working independently in a solo role
• Fluency in Dutch or English
• Detail-oriented with the ability to meet deadlines
• Strong analytical, problem-solving, and risk management skills
• Excellent communication skills
• Experience with ISO 27001, NEN 7510, and understanding of ISO 13485 is a plus

Quin offers:

• Competitive salary and benefits package
• Opportunity to work in a growing, innovative company
• Professional development and training opportunities
• A dynamic and supportive team environment