QA Engineer (Evry, France)

The QA Engineer provides the necessary support to department managers and process owners in order to develop and maintain their parts of the quality management system.

YOUR MISSION:

• Manage different quality certifications for the OncoDNA group such as ISO 13485, CLIA CAP
• Accountable for maintaining the appropriate certifications, such as CLIA-CAP accreditation and CE marking of products according to the new CE-IVDR procedure
• Participate in the daily tasks necessary to maintain an auditable quality management system (Document management, NC, CAPA, change management, monitoring of indicators, internal audits, supplier evaluation, management review, risk review, risk analysis, ensuring that equipment maintenance and qualification of equipment is carried out, etc.)
• Prepare product and process quality reports by collecting, analysing, and summarizing information and trends.
• Provide technical leadership and expertise within the field of Quality Assurance related to operations and projects.
• Optimisation of Qualishare.
• Update of the HSE process.

YOUR PROFILE

• You hold an University degree in Science, Biology or Engineering
• A first experience (2-3 years) in Quality Assurance including Solid regulatory compliance knowledge, including GCP, ISO 13485, CLIA-CAP
• Sound understanding of local and international regulatory and compliance requirements and ability to interpret, analyse and apply appropriate legislation.

Soft Skills

• Strong organizational agility with ability to successfully operate in a matrix or team environment across multiple locations, countries and regions.
• Ability to successfully handle multiple responsibilities, priorities and tasks
• Ability to manage complex projects on time and within budget
• Strong written and verbal communication skills in both UK and FR