Supplier Quality Management Technician
hace 7 días
Supplier Quality Management Technician
Responsibilities
Within the competencies and responsibilities assigned to the Supplier Quality Management department and for all B. Braun group companies in Spain managed from the Quality Management CoE OR Supply area:
- Supervise the quality compliance of assigned suppliers (suppliers of raw materials and/or subcontracting and/or services and/or finished products). Ensuring compliance with regulations and procedures applicable to different types of products (pharmaceutical, medical, veterinary, etc.).
- Manage or coordinate quality contracts, confidentiality agreements, raw material specifications, or technical agreements for assigned suppliers and/or materials.
- Actively participate in the annual evaluation of suppliers.
- Coordinate or participate in the change control processes of assigned suppliers and/or materials.
- Support during the qualification and approval processes of assigned suppliers and/or materials.
- Participate in internal audits, external audits by clients, authorities, and notified bodies.
- Work closely with multifunctional project teams to identify and mitigate quality risks. Prepare or participate in the risk analysis of processes and products related to suppliers.
- Lead or participate in improvement proposals, solutions to optimize workflows, corrective actions, and continuous improvement activities using the most appropriate methodologies and techniques.
- Collaborate closely with the Purchasing and other B. Braun departments to improve and develop the supplier panel.
Minimum Requirements
- Engineering degree in materials, industrial or chemical or Chemistry.
- 7 years of experience in Medical Device, Pharma or Automotive sector.
- 5 years of experience in a similar position.
- Experience with finished products suppliers is valued.
- Knowledge with: GMP, ISO 13485, ISO 14971, ISO 9001, EU MDR, FDA CFR 21 QSR 820, ISO 19011.
- Experience as lead supplier auditor.
- Advanced MS Office (Excel and Power BI).
- High level of English for interaction with international suppliers, colleagues and writing technical reports and documentation.
- Incident management, quality control and continuous improvement.
- SAP knowledge is a plus.
- Be proactive, responsible and value diversity.
- Communication, teamwork and troubleshooting skills.
- High capacity for observation and analysis.
- Availability to travel.
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