Quality Assurance Engineer

Overview

Our client is looking for a talented Quality Assurance Engineer to join their team in Geneva. The Quality Assurance Engineer will play a key role in ensuring the quality and safety of our medical devices throughout the manufacturing process, from design and development to production and distribution.

• Develop, implement, and maintain quality assurance processes and procedures in compliance with regulatory requirements and industry standards (e.g., ISO 13485, FDA QSR).
• Review and approve design and process changes to ensure they meet quality and regulatory requirements.
• Perform risk assessments and analysis of product and process changes to identify potential quality issues and develop mitigation strategies.
• Conduct internal audits and assessments to evaluate compliance with quality management systems and identify areas for improvement.
• Collaborate with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain to address quality issues and drive continuous improvement.
• Investigate and resolve product quality issues, non-conformities, and customer complaints, implementing corrective and preventive actions as necessary.
• Support supplier quality management activities, including supplier qualification, audits, and performance monitoring.
• Participate in regulatory inspections and external audits, providing documentation and support as needed.

• Bachelor’s degree in engineering, quality assurance, or a related field; advanced degree preferred.
• 3+ years of experience in quality assurance or regulatory affairs in the medical device industry.
• Strong knowledge of quality management systems, regulations, and standards applicable to medical devices (e.g., ISO 13485, FDA QSR, MDD/MDR).
• Experience with risk management methodologies (e.g., ISO 14971) and quality tools such as FMEA, CAPA, and statistical analysis.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.
• Effective communication and collaboration skills, with the ability to work cross-functionally and influence stakeholders at all levels.
• Fluency in English and French.