Quality Assurance Officer

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 of 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 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 : Bachelors 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 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.

Remote Work : Yes

Employment Type : Full-time

Key Skills

Graphic Designing,Information Technology Sales,IT Services,Accounts,Auto Parts,Import & Export

Experience

years

Vacancy

1

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