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.
Responsibilities:
- 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.
Requirements:
-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