Quality Assurance Officer

SGS Australia; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in testing and certification is seeking a Quality Assurance professional for a remote role focused on maintaining the medical device quality management system. The ideal candidate should have a degree in Biomedical Sciences, strong knowledge in QA systems, and experience in medical devices. This position involves managing complaints, document control, and regulatory compliance while supporting continuous improvement efforts.

Servizi

Flexible schedule

Hybrid model

Continuous learning options

Multinational environment

Benefits platform

Competenze

• Significant work experience in a position with QA responsibility.
• Experience working with medical devices is a plus.
• Auditing experience against recognised standards is advantageous.

Mansioni

• Manage internal quality management system for medical devices.
• Handle daily quality assurance tasks and document maintenance.
• Collaborate on generic scheme documents and manage databases.
• Ensure compliance with regulatory expectations and support development.

Conoscenze

Good working knowledge of quality management systems

Detail oriented

Strong organisational skills

Ability to organise own workload

Ability to adapt quickly

Ability to work in a team

Ability to write clear procedures

Good working knowledge of MS Office tools

Fluent written and spoken English

Formazione

Bachelor's degree in Biomedical Sciences or similar

Descrizione del lavoro

Company Description

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.

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 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.

Qualifications

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, ...)

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.

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 continuos 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.