Quality Assurance Officer

SGS; España; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A global leader in testing, inspection, and certification is seeking a QA professional in Spain for maintaining quality management systems and managing regulatory compliance. The ideal candidate will have a Bachelor's degree in Biomedical Sciences and significant QA experience. Key responsibilities include managing complaints and document control, along with providing technical support across the business. The role is hybrid, offering flexibility, and is open to candidates across Europe with valid work permits.

Servicios

Flexible schedule

Hybrid work model

Continuous learning options

Benefits platform

Formación

• Good working knowledge of CAPA management and good documentation practices.
• Ability to adapt quickly and demonstrate flexibility.
• Ability to write clear procedures.

Responsabilidades

• Manage complaints, compliance queries, and appeals.
• Perform quality assurance checks on updated quality management system documents.
• Build good working relationships with Global Medical Device Team members.

Conocimientos

Quality management systems

Detail-oriented

Strong organisational skills

Teamwork

Fluent English

Educación

Bachelor's degree in Biomedical Sciences or similar

Herramientas

MS Office (Word, Excel, Outlook)

Descripción del empleo

Company Description

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.

Job Description

Main Purpose of Role:

• 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.

Key Accountabilities

• 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.

Essential Qualifications & Knowledge

• 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.

A Nice to Have

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

Essential Experience

• Significant work experience in a position with QA responsibility.

Essential Academic Qualification

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

Performance Indicators

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

Please send your CV in English.

Additional Information

Why SGS?

• 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.

Join Us

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.

Videos To Watch

https://www.youtube.com/watch?v=vso_LZuxki4