Quality Assurance Engineer

Gefunden in: beBee jobs CH - Vor 6 Tagen

Genf, Genf, Schweiz Cpl Vollzeit

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 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

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