Quality Technician

hace 3 semanas

Barcelona, España B. Braun Surgical S.A. A tiempo completo

We are looking for a Quality Technician - Sterilization for a vacancy in the QRA Department of B.Braun Surgical, S.A. from Monday to Friday, full-time.

**Duties and responsibilities**:

- 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 accordingly.
- 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.

**Professional competencies**:

- 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 EO and/or GAMMA sterilization processes.
- Knowledge in statistical methods preferred.
- Experience in Validations, Project Management, IT Systems Implementation preferred.
- High level of English
- Knowledge of Spanish preferred.

**Personal competencies**:

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

**What we offer**:
Join a company that combines the innovation and agility of a start-up with the stability and global reach of a healthcare leader. By working with us, you'll be part of a team dedicated to improving people's health and healthcare services. Our corporate culture values accountability, diversity, and trust. Embrace a highly motivated international team, flat hierarchies, and fast decision-making. Barcelona, a vibrant city with a high quality of life, is an ideal location for you to grow professionally and personally.

**Closing date**:

- 22.03.2024

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