Quality Engineer
Le agradecemos el interés mostrado en la posición Quality Engineer. Desafortunadamente esta oportunidad de trabajo está cerrada, pero puede consultar nuestras 1,349 ofertas de trabajo haciendo clic aquí.
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.
