Senior Quality Systems Specialist

5 hours ago


Slough, Slough, United Kingdom GxPeople Global Full time
About the Role

The Senior Quality Systems Specialist will be responsible for supporting the QA/RA team with issues related to overall quality assurance, control, and compliance. This includes taking full ownership of the areas of Quality Management System (QMS).

The ideal candidate will have experience in Medical Device Manufacturing, with a strong working knowledge of ISO 13485:2016, MDSAP, and Medical Devices Directive (93/42/EEC). They will also have Lead Auditor training and certification, as well as knowledge of IEC 60601 standards.

The salary for this position is estimated to be around $115,000 per year, based on industry standards and the level of experience required.

Key Responsibilities
  • Support device testing activities (IEC 60601-1, 60601-1-2 etc)
  • Assist in preparation of Technical Files
  • Provide QMS Induction training for new starters
Benefits

GxPeople Global offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.



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