Quality Assurance Officer

SGS; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leader in testing, inspection, and certification is seeking a Quality Assurance professional to maintain the internal quality management system of medical devices. This remote role involves managing QA tasks, complaints, compliance issues, and fostering relationships within a global team. The ideal candidate will have a Bachelor's degree in a related field, experience in QA, and a good understanding of medical device regulations. This position offers flexibility and opportunities for continuous professional development.

Benefits

Flexible schedule and hybrid model

Continuous learning options at SGS university

Benefits platform

Qualifications

• Significant work experience in a position with QA responsibility.
• Good working knowledge of CAPA management and good documentation practices.
• Detailed understanding of global medical device regulations is a plus.

Responsibilities

• Maintain the internal quality management system for medical devices.
• Manage complaints and compliance queries.
• Support development and maintenance of scheme documents.

Skills

Quality management systems

Document control

Organisational skills

Proficient in MS Office tools

Fluent in English

Education

Bachelor's degree in Biomedical Sciences or similar field

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

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, adaptability, teamwork, clear procedure writing, proficiency in MS Office tools, fluent written and spoken English.

Nice to have: Detailed understanding of global medical device regulations MDR and IVDR and medical device directive MDD, knowledge of accreditation standards ISO 17021-1:2015, ISO 13485, ISO 9001, experience working with medical devices, auditing experience against recognised standards.

Experience

Essential: Significant work experience in a position with QA responsibility.

Nice to have: Experience working with medical devices, auditing experience against recognised standards.

Qualifications (Education)

Essential: Bachelors degree (or higher) in Biomedical Sciences or similar field (e.g. pharmacy, bioengineering, nurse...).

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.

Remote Work

Yes

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 continuous 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.