Quality Assurance Officer (1 year maternity cover)

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 flexible 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.