Quality Assurance Engineer

☞ CPL Recruitment

Vue: 109

Jour de mise à jour: 11-04-2024

Localisation: Genève Genève GE

Catégorie: Conseil / Service client

Industrie:

Loading ...

le contenu du travail

    Posted date07 March 2024

    LocationGeneva

    Job type Permanent

    SalaryNegotiable

    Discipline Life Sciences

    ReferenceJO-2403-531307


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
Loading ...
Loading ...

Date limite: 26-05-2024

Cliquez pour postuler pour un candidat gratuit

Postuler

Signaler des emplois
Loading ...
Loading ...

MÊMES EMPLOIS

Loading ...
Loading ...