Quality assurance consultant (m/w/d)

I am looking for an experienced Quality assurance consultant to support a Medical device company for a 4 months project.

Starting date: August 2023

Responsibility:

• To establish and maintain procedures relative to quality documentation
• To provide support on quality system procedures
• To perform quality assurance review and facilitate the release of production batch
• To manage and monitor of CAPAs and non-conformities
• To participate in the audit, approval of suppliers, ensuring high-quality inputs for manufacturing process.
• To support in the Process Validation activities
• To support in preparing regulatory submissions in Europe and the USA.

Knowledge, Skills and Abilities:

• Bachelor’s or Master’s degree in Quality, Mechanical, Biomedical Engineering, or a related field
• Knowledge of quality systems, quality assurance techniques, and regulatory standards (e.g. ISO 13485 and FDA 21 CFR)
• Proficiency in the use of statistical analysis and quality improvement tools
• Proficiency in documenting all work reliably and accurately as per QMS standards
• Minimum 4 years of experience in a Quality Engineering role in a medical device manufacturing
• Experience in implementing and managing CAPA systems.
• Fluent in English and French