Quality Engineer
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JOB QUALIFICATIONS
- Ensures that documents are continuously reflecting the reality of business processes while complying with regulations, Corporate Policies and Spinal and Biologics Business requirements.
- Provide support in implementing, keeping up to date and ensuring execution of the validation plan for equipments, processes, and automated and computerized systems.
- Conducts validation activities (protocol, execution, report) including test method validation.
- Assists R&D, Manufacturing Engineers and other Quality team members with validation and qualification studies and product testing activities.
- Supports activities concerned with development, application, and maintenance of quality standards for industrials processes, materials and products.
- Assists for CAPA investigation, including non-conformities, recalls, complaints, audit results.
- Responsible for ensuring that design phase of processes, equipment, and IT support applications match both anticipated business needs and user needs: from URS to detailed specification, with addressed partners and end-users.
- Ensures that all equipments, processes and IT applications used for regulated activities are validated and maintained in the appropriate validation status.
- Supports the design process review and complete risk management activities for products for which Kyphon Sàrl is legal manufacturer.
- Participates to specific requirement adaptation for product design to meet regulatory compliance objectives (e.g. FDA, Japan…).
- Respects the independence principle between design and validation.
- Review and approval of validation documents, change requests, maintenance / calibration documents
- Ensures that all quality tools developed tend to paperless, accessible and user-friendly solutions (e.g. portal).
- Performs others activities as required.
Languages
- Good communication skills, both verbal and written of French and English.
