Mantell Associates
Mantell Associates is currently partnered with an innovative Medical Devices organisation, who are seeking a Quality System Engineer to join their team.
Quality System Engineer – Responsibilities:
- Reporting to the System Quality Manager, represent System Quality to other departments
- Ensure the organization’s compliance with applicable system requirements and specific regulations of the countries they work with
- Ensure the compliance and relevance of the provisions implemented
- Manage and lead the CAPA process, from registration to closure, ensuring the monitoring and completion of actions within defined deadlines
- Manage Quality documentation, maintaining EDM functionality, and providing support to users
- Carry out internal and external audits and ensure that the corrective actions identified are implemented
- Prepare and participate in regulatory inspections and third-party audits
- Provide training to staff in Good Manufacturing Practices and system requirements
- In support, coordinate the recording, evaluation, and monitoring of Change controls until their closure
Quality System Engineer – Responsibilities:
- With a Bac+5 qualification in Quality, you have initial experience of 3 to 5 years in a System Quality Assurance position in the Medical Device sector
- You are familiar with the ISO13485 standard, Directive 93/42CEE, and the new regulation MDR2017/745
- You practice good methods of investigation and problem solving and know the tools and methods of CAPA management
- Naturally curious, you are proactive and have strong adaptability skills
- Rigorous, autonomous and with very good interpersonal skills, you have a very good team spirit and cohesion
- Fluent in English & French
- Willingness to be on site (hybrid)
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.