Experienced Quality Assurance Specialist

4 days ago


Caerphilly, United Kingdom Yolk Recruitment Full time

Job Summary:

We are seeking a highly skilled Quality Engineer to join our client's growing operation in the Medical Device industry. As a Quality Engineer, you will play a crucial role in ensuring regulatory compliance and quality standards are met.

Key Responsibilities:

  • Collaborate with the Head of Quality Assurance and manufacturing associates to ensure compliance with regulatory and customer requirements.
  • Monitor and analyze critical to quality features in production, identifying trends and providing early warnings of potential quality issues.
  • Maintain adherence to internal quality management system procedures and processes, in line with ISO 13485 and the Medical Device Directive 93/42/EEC.

Requirements:

  • 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.
  • In-depth knowledge of applicable regulatory requirements, including Medical Device Directive 43/92/EEC.
  • Proficient in continuous improvement techniques, procedure and report writing.

About the Company:

Our client is a prominent Medical Device company that values quality and regulatory compliance. As a Quality Engineer, you will have the opportunity to make a real impact and contribute to the success of the company.



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