Quality Assurance Coordinator

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 :

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 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.

Remote Work :

Yes

Employment Type :

Full-time

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Industry,ICH Q7,ISO 9001,Hospice Care,Food Processing,Quality Management,cGMP,QA / QC,HACCP

Experience : years

Vacancy : 1

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