Description
As we are approaching the launch of our instrument system as well as the associated sample preparation kits and reagents, we are currently looking for a QA/regulatory representative to implement the quality system of the company.
As a Quality assurance and regulatory manager at Depixus, you will:
· Design & implement the quality policy
· Liaise with department representatives
· Implement and support quality management system (QMS/GED)
· Train team members to the use of the system and encourage good practices
· Redact and keep updated high quality documentation in constant connection with the appropriate teams and across teams
· Implement and follow up deviation, CAPA and change control
· Ensure regulatory requirements are followed
· Keep up to date to the latest regulatory requirements or guidelines relevant to the field
· Participate in the risk analysis as well as the implementation of actions to mitigate these risks
· Establish internal audits for product fabrication
· Review and approve the future products release (RUO kits)
· Review and approve documentations intended to customers
This role would suit you if you:
· At least 5 years of relevant experience in Quality Management
· Demonstrate good organisational skills
· Have sharp attention to details
· Have knowledge of using a QMS
· Have knowledge and experience in the regulatory landscape of RUO kits (Experience with regulation around CE—IVD kit production will be seen as favourable), experience in reagents would be appreciated
· Have good interpersonal and communication skills allowing to support the implementation of the quality management system across various department and sites
· Integrity, critical and analytical thinking, cooperation, team spirit and proactivity are essential
· Able to communicate in English and French, both in writing and orally
· Enjoy working in a dynamic start-up environment
Recruitment process
· Visio interview with the HR team
· Technical test
· Technical interview
· Final interview on site
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