Quality Assurance Specialist

7 days ago


Caerphilly, United Kingdom CV Library Full time

Quality Assurance Specialist


Salary: £40,000 - £50,000 DOE


CV Library is exclusively partnered with this prominent Medical Device company in their search for a talented Quality Assurance Specialist to join a growing operation.

We're looking for someone passionate about Quality and ensuring regulatory compliance, with experience in quality within medical devices, and who in turn is looking to develop their career in a business that truly values Quality.

This is your chance to make a real impact and contribute to the success of a growing organisation who are specialists in their field.

Key Responsibilities:
  1. Collaborate with the Head of QA and manufacturing associates to ensure compliance with regulatory and customer requirements.
  2. Monitor and analyse critical to quality features in production, identifying trends and providing early warnings of potential quality issues.
  3. Maintain adherence to internal quality management system procedures and processes, in line with ISO 13485 and the Medical Device Directive 93/42/EEC.
Requirements:
  1. Previous experience in a quality-related field within a Medical Device design environment or a similar regulatory-controlled setting.
  2. Comprehensive knowledge and understanding of quality standards such as ISO 9001 and ISO 13485.
  3. Proficiency in quality and business management systems.
  4. Strong background in quality inspection and implementation of corrective action programs.
  5. Experience with product or industry-specific quality requirements.
  6. Solid computer skills and familiarity with quality tools, concepts, and methodologies.
  7. In-depth knowledge of applicable regulatory requirements, including Medical Device Directive 93/42/EEC.
  8. Proficient in continuous improvement techniques, procedure and report writing.


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