Biotecnologia à Espagne

We are SGS – the world’s leading testing, inspection and certification company. We are recognised as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future‑oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

• Maintenance of the NB 1639 medical device internal quality management system.
• Managing of daily QA tasks:
  • Updating and maintenance of documents under the MDD, MDR and IVDR scheme.
  • Management of the IF database.
  • Collaboration on generic scheme documents.
  • Publishing of documents on the SGS website.
  • Bizzmine (Quality Management System); user communication and maintenance.

Report to the Quality & Regulatory Manager, Business Assurance.

Remote based – open to candidates located anywhere across Europe who hold a valid work permit for their country of residency.

• Management of complaints, compliance queries and appeals.
• Management of continual improvement.
• Management of document control and records.
• Perform quality assurance checks on updated quality management system documents.
• Release of updated quality management system documents in Bizzmine.
• Build a good working relationship with the Global Medical Device Certification / Competency / Technical and Clinical Manager(s), and other Global Medical Device Team members.
• Undertake personal professional development and ensure appropriate training records are updated.
• Provide technical support to all parts of the business.
• Maintain a full knowledge and understanding of SGS procedures, regulations, guidance documents (e.g., MDCG) and external approval criteria.
• Support the development and maintenance of combined scheme documents.

• Good working knowledge of quality management systems including CAPA management, document control and good documentation practices (GDP).
• Detail oriented.
• Strong organisational skills.
• Ability to organise own workload considering priorities set by the global medical device quality manager.
• Ability to adapt quickly and demonstrate flexibility.
• Ability to work in a team.
• Ability to write clear procedures.
• Good working knowledge of the main MS Office tools (Word, Excel, Outlook).
• Fluent written and spoken English.
• Detailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDD.
• Knowledge of accreditation standards ISO 17021‑1:2015, ISO 13485, ISO 9001.

• Experience working with medical devices.
• Auditing experience against recognised standards.
• Medical device training on MDD, MDR, IVDR or ISO 13485.
• Medical device auditor.

• Significant work experience in a position with QA responsibility.

• Bachelor's degree (or higher) in Biomedical Sciences or a similar field (e.g., pharmacy, bioengineering, nursing).

• Turnaround time for compliance issues/complaints/appeals.
• Efficient running of the QMS and release of quality management documents.

Please send your CV in English.

• Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuous learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

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