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Quality Assurance Specialist

2 months ago


Caerphilly, United Kingdom Yolk Recruitment Ltd Full time
p>Are you a quality enthusiast looking to make a meaningful impact in a dynamic Medical Device company? We have an exciting opportunity for a skilled Quality Engineer to collaborate with our client, a prominent Medical Device company, in ensuring regulatory compliance and quality excellence.

As a Quality Engineer, you will be responsible for:

  • Collaborating with the Head of QA and manufacturing associates to ensure adherence to regulatory and customer requirements.
  • Monitoring and analyzing critical to quality features in production, identifying trends and providing early warnings of potential quality issues.
  • Maintaining adherence to internal quality management system procedures and processes, in line with ISO 13485 and the Medical Device Directive 93/42/EEC.

Key qualifications for this role include:

  • Previous experience in a quality-related field within a Medical Device design environment or a similar regulatory-controlled setting.
  • Comprehensive knowledge and understanding of quality standards such as ISO 9001 and ISO 13485.
  • Proficiency in quality and business management systems.
  • Strong background in quality inspection and implementation of corrective action programs.
  • Experience with product or industry-specific quality requirements.
  • Solid computer skills and familiarity with quality tools, concepts, and methodologies.
  • Proficient in continuous improvement techniques, procedure and report writing.

At Yolk Recruitment Ltd, we are committed to supporting our clients in finding the best talent for their organizations. If you have the skills, experience, and passion to excel in the role of Quality Engineer, we encourage you to apply.