Main Purpose of Role:
Maintenance of the NB 1639 medical device internal quality management system.
Managing of daily QA tasks:
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 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.
Please send your CV in English
Additional Information :
Why SGS
Join Us: At SGS we are dedicated to fostering an open friendly and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn grow your expertise and fulfill your potential.
Please share your CV in English. The role is fully remote. People from other countries can apply as well.
Remote Work :
Yes
Employment Type :
Full-time
Experience: years
Vacancy: 1
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