Quality Assurance Officer (1 year maternity cover)

SGS; Milano; In loco; EUR 55.000 - 70.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible schedule

Access SGS University and Campus

Multinational environment

Comprehensive benefits platform

Descrizione del lavoro

SGS is seeking a Quality Assurance Officer on a 1-year maternity cover to maintain the NB 1639 medical device internal quality management system across Europe. You will update documents under MDD, MDR and IVDR schemes and manage the Bizzmine QMS alongside the Global Medical Device team.

Based remotely across Europe, you will collaborate with the Quality & Regulatory Manager and other departments to ensure compliant documents, CAPA processes, and robust records, while supporting continuous

Competenze

• Bachelor's degree or higher in Biomedical Sciences or similar field.
• Significant work experience in a QA role with medical devices.
• Knowledge of MDR/IVDR, MDD and ISO 13485 is preferred.
• Fluent written and spoken English.
• Excellent documentation and GDP practices.

Mansioni

• Maintenance of the NB 1639 medical device internal quality management system.
• Update and maintain documents under the MDD, MDR and IVDR scheme.
• Manage the IF database and collaboration on scheme documents.
• Publish documents on the SGS website and maintain Bizzmine records.
• Provide technical support to all parts of the business.
• Release updated QMS documents in Bizzmine.
• Ensure training records are up to date and aid continuous improvement.

Conoscenze

Quality management systems

CAPA management

Document control

GDP

Detail oriented

Organizational skills

Written procedures

MS Office (Word, Excel, Outlook)

Fluent English

Team collaboration

Formazione

Bachelor’s degree in Biomedical Sciences or similar

Strumenti

Bizzmine

Descrizione del lavoro

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.