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