Quality Assurance Officer (1 year maternity cover)

- Full-time

We are SGS – the world's leading testing, inspection and certification company. We are recognized 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.

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 the IF database,
- Collaboration on generic scheme documents,
- Publishing of documents on the SGS website,
- Bizzmine (Quality Management System); user communication and maintenance.

This role will report to the Quality & Regulatory Manager, Business Assurance.

It is remote based, and we are open to candidates located everywhere across Europe. But they must 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 check 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.

Skills & 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.

A nice to have:

- Detailed understanding of global medical device regulations MDR and IVDR, and medical
- Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001.

Experience

- Significant work experience in a position with QA responsibility.

A nice to have:

- Experience working with medical devices,
- Auditing experience against recognised standards.

Qualifications

- Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar)

A nice to have:

- Medical device training on MDD, MDR, IVDR or ISO 13485

Performance Indicators:

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

Why SGS?

- Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
- Enjoy a versátil schedule andwork model.
- Access SGS University and Campus for continuous learning options.
- Thrive in a multinational environment, collaborating with colleagues from multiple continents.
- Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.

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📌 Quality Assurance Officer (1 year maternity cover) (Madrid)
🏢 SGS
📍 Madrid