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Quality Engineer

Yolk Recruitment Ltd
Job LocationCaerphilly
EducationNot Mentioned
Salary£50,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Quality Engineer£40,000 - £50,000 doe CaerphillyAre you passionate about quality and ensuring regulatory compliance Do you have experience in a quality-related field within a Medical Device environment If so, we have an exciting opportunity for a skilled Quality Engineer to join our dynamic team.At Yolk Recruitment, we are proud to support our client, a prominent Medical Device company, in their search for a talented Quality Engineer. This is your chance to make a real impact and contribute to the success of a growing organisation who are specialistsin their field!This is what youll be doing as Quality Engineer:

  • Collaborate with the Head of QA and manufacturing associates to ensure compliance with regulatory and customer requirements.
  • Monitor and analyse 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.
  • Work closely with the R&D department to ensure design control activities align with ISO 13485 and other relevant standards.
  • Assist in the compilation and review of Standard Operating Procedures, Work Instructions, and other documentation to ensure compliance with ISO 9001, ISO 13485, and ISO 14001.
The experience youll bring to the team as Quality Engineer:
  • 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.
  • Internal auditor certification to ISO 13485 and ISO 14001 standards is a plus.
  • 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.
Are you up to the challengeIf you feel you have the skills, experience and passion to be successful in the role of Quality Engineer apply now.*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have beenunsuccessful. Please keep an eye on our website for more opportunities.

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