Quality Assurance Officer (1 year maternity cover)

SGS Italia; Milano; Remote; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

SGS is seeking a QA professional to maintain the NB 1639 medical device internal quality management system and handle daily QA tasks in line with MDD, MDR and IVDR requirements.

The role reports to the Quality & Regulatory Manager, Business Assurance. It is remote-based, open to candidates across Europe with valid work permits, and requires a Biomedical Sciences background and strong English skills.

Qualifikationen

• Bachelor’s degree in Biomedical Sciences or similar field.
• Experience in QA with medical devices or related sector.
• Knowledge of CAPA, document control and GDP.
• Fluent written and spoken English.
• Understanding MDR/IVDR, MDD and ISO 13485 is a plus.
• Ability to draft clear procedures and work in a team.

Aufgaben

• Maintain NB 1639 internal quality management system.
• Manage daily QA tasks: update MDD/MDR/IVDR docs and IF database.
• Publish documents on Bizzmine and SGS website; user communications.
• Collaborate with Global Medical Device teams and colleagues.
• Ensure training records are updated and support QC.
• Support development of combined scheme documents.

Kenntnisse

CAPA management

Document control

GDP

Detail oriented

Organisational skills

Workload management

Team collaboration

Procedures writing

MS Office

English proficiency

Ausbildung

Bachelor’s degree in Biomedical Sciences or similar

Tools

Word

Excel

Outlook

Jobbeschreibung

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

Essential

• 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 device directive MDD,
• Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001.

Experience

Essential

• Significant work experience in a position with QA responsibility.

A nice to have

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

Qualifications

Essential

• 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
• Medical device auditor

Performance Indicators

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