Quality Assurance Engineer

3 weeks ago


Manchester, United Kingdom GxPeople Global Full time

About the Role:

GxPeople Global is collaborating with a leading Medical Device Manufacturer to recruit a Quality Engineer or Senior Quality Engineer. This role is pivotal in ensuring the highest standards of quality within the organization.

Key Responsibilities:

  • Oversee Supplier Management, including SCARS, KPIs, Supplier Assessments, Agreements, requalification, and monitoring.
  • Conduct external audits of suppliers to ensure compliance and quality standards.
  • Manage Non-conformances, including NCMR and CAPA processes.
  • Address Customer Complaints effectively and efficiently.
  • Perform thorough Product Inspections to maintain quality assurance.
  • Review, inspect, and authorize product labels to ensure accuracy.
  • Evaluate and approve Device History Records (DHR) and other essential production documentation.
  • Execute Product Release procedures with precision.
  • Revise existing Quality Management System (QMS) documentation, including SOPs and WIs.
  • Contribute to the development of new QMS procedures to enhance operational efficiency.

Essential Qualifications:

  • Familiarity with ISO13485 standards and compliant processes.
  • Experience in Quality Assurance, with a preference for Quality Control in the medical device sector.
  • A degree or relevant quality qualification is required.
  • A minimum of 2 years of experience in a related field is essential.

If you are interested in exploring this opportunity further, please reach out for more information.



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