From B. Braun Surgical, we are looking for a Quality Sterilization Technician for a vacancy in the QRA Department located in Rubí.

Responsabilities

• Responsible for ensuring compliance with legal and regulatory aspects that apply to sterilization processes.
• Ensures the correct implementation of the requirements of the B. Braun Surgical, S.A. (BBSES) quality management system, especially those related to sterilization.
• Responsible for the management of the quality aspects related to the sterilization processes of BBSES products and their validations and revalidations.
• Coordinates and participates in sterilization process validation activities.
• Participates in product transfers between production sites regarding the associated sterilization processes.
• Collaborates with the Engineering department in the reception, start-up and qualification of new sterilization equipment, processes and facilities.
• Follows up results, trends and actions related to sterilization processes.
• Manages responses to health authorities regarding sterilization processes.
• Is responsible, when applicable, for the definition or revision of standard operating procedures (SOPs) for sterilization processes, specifications and inspection plans, as well as ensuring their compliance.
• Participates in BBSES system, production plant, product or supplier audits.
• Is responsible for preparing or collaborating in quality management system reports.
• Ensures the continuous improvement of the organization and its processes; improvement of the technical, economic and design characteristics of sterilization equipment and processes.
• Is responsible for or collaborates in the implementation, follow-up and verification of the effectiveness of corrective, preventive or improvement actions.
• Participates in working groups for risk analysis of products and processes.
• Documents, investigates and manages, when applicable, product and process nonconformities.
• Collaborates with Engineering on internal sterilization process training and validation.
• Participates as a leader or member of project teams managing the resources assigned to his/her area of responsibility.
• Participates in the Change Control process when changes are related to the quality management system or sterilization processes.
• Participates in the technical support for the resolution of product incidents in the market.

Requirements

• Studies Engineering or Bachelor of Science.
• 5 years experience in Medical Devices, Pharma sector, performing the same functions.
• Knowledge of ISO 13485, ISO 11135, ISO 11137 standards.
• Experience in ETOX and/or GAMMA sterilization processes.
• Experience in statistical knowledge.
• Experience in Validations, Project Management, IT Systems Implementation.
• High level of English and Spanish

Personal skills

• High capacity of solving problems to achieve a positive result.
• High organizational skills: ability of multitasking, task prioritization, compartmentalizing projects and documenting everything for easy access and future reference.
• Team spirit and leadership skills.

If you believe your experience and professional interests are align with the offer, don´t hesitate to apply!

B. Braun Surgical, S.A.U. | Victoria Merodio