From B. Braun Surgical, we are looking for a Quality Technician - Sterilization for a vacancy in the QRA Department located in Rubí .
Responsibilities
* Ensure compliance with legal and regulatory standards related to sterilization processes.
* Implement requirements of the B. Braun Surgical, S.A. (BBSES) quality management system, especially those pertaining to sterilization.
* Manage quality aspects of sterilization processes for BBSES products, including validations and revalidations.
* Coordinate and participate in sterilization process validation activities.
* Participate in product transfers between production sites concerning sterilization processes.
* Collaborate with Engineering in the reception, start-up, and qualification of new sterilization equipment, processes, and facilities.
* Monitor results, trends, and actions related to sterilization processes.
* Manage responses to health authorities regarding sterilization processes.
* Define or revise standard operating procedures (SOPs), specifications, and inspection plans for sterilization, ensuring compliance.
* Participate in audits of BBSES systems, production plants, products, or suppliers.
* Prepare or assist in preparing quality management system reports.
* Promote continuous improvement of processes and organization, including technical, economic, and design enhancements of sterilization equipment and processes.
* Implement, follow-up, and verify the effectiveness of corrective, preventive, or improvement actions.
* Participate in risk analysis workgroups for products and processes.
* Document, investigate, and manage product and process nonconformities.
* Collaborate with Engineering on internal training and validation of sterilization processes.
* Lead or participate in project teams managing resources within the area of responsibility.
* Engage in Change Control processes related to quality system or sterilization processes.
* Provide technical support for resolving product incidents in the market.
Requirements
* Degree in Engineering or Bachelor of Science.
* At least 5 years of experience in Medical Devices or Pharma sector performing similar functions.
* Knowledge of ISO 13485, ISO 11135, ISO 11137 standards.
* Experience with ETOX and/or GAMMA sterilization processes.
* Statistical knowledge.
* Experience in Validations, Project Management, and IT Systems Implementation.
* Proficiency in English and Spanish.
Personal Skills
* Strong problem-solving abilities to achieve positive results.
* Excellent organizational skills, including multitasking, prioritization, documentation, and project management.
* Team spirit and leadership capabilities.
If your experience and professional interests align with this opportunity, don’t hesitate to apply!
#J-18808-Ljbffr