Stilla is hiring a Quality & Regulatory Manager

Missions for the Quality Manager
The Quality & Regulatory Manager ensures Stilla’s transition toward the clinical market. He/she drives the implementation of the Quality Management System and coordinates with external partners for regulatory compliance. He/she is responsible for the certification of the Naica system for diagnostic use in Europe, the USA, and Asia.

1. Put in place a Quality Management System compliant with ISO 13485
– Define and maintain Stilla’s Quality Policies and Quality Manual in collaboration with the Management
– Identify and prioritize actions to put in place a QMS, more particularly:
• Design processes structure and key performance indicators with identified pilots
• Organize and optimizin document management, non-conformities and CAPAs
• Record and coordinate the resolution of quality issues (complaints, non-conformities) with CAPAs follow-up
• Plan, perform and coordinate internal audits (including suppliers’) as well as external audits (from customers, notified bodies or regulatory authorities)
• Ensure regulatory and standards watch
• Evaluate suppliers in collaboration with Purchasing and R&D department
• Prepare and coordinate the management review of the QMS
– Make all existing processes, methods and tools compliant
– Coordinate and train teams to put in place and comply with the QMS
– Monitor and report progresses

2. Ensure regulatory approval for the Naica system
– Coordinate with external partners for quality and regulatory assurance
– Provide expertise and training to the teams regarding the regulatory requirements
– Participate in the definition of product intended use, positioning and claims from RUO to IVD, and ensure its consistency with product risk analysis
– Put in place Product Life Cycle management tools and Change Management tools
– Coordinate and train teams to perform product risk analysis including change control
– Source and manage external partners to help certify the Naica system
– Negotiate quality agreements with key suppliers
– Prepare and collect all documents required for CE-IVD certification of instruments, consumables, software and assays/kits
– Maintain technical documentation to regulatory and standards state-of-the-art, as well as change management

 

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