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Quality Assurance Specialist

Job LocationCorsham
EducationNot Mentioned
Salary£30,000 - £37,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

A market leading medical device producer are currently experiencing huge growth.They are seeking a Quality Assurance Specialist to drive their quality management and compliance function and rive process improvements.The successful candidate will ensure continued compliance and improvement of the Quality Management process with the relevant regulatory requirements and ensure that these are continually maintained and implemented in the best way possible.Responsibilities:

  • Ensure compliance with the relevant European Medical Device Regulatory requirements; ISO 13485:2016, EU 2017/745, ISO 14971.
  • Ensure regulatory requirements are continually maintained and implemented in the best way possible.
  • Regularly generate, review and amend quality system documentation to make sure it is accurate and fit for purpose.
  • Undertake QA responsibilities regarding failure investigations, hold and recall investigations and risk assessments
  • Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored.
  • Perform internal audits to ensure compliance to external regulations.
  • Support external audits.
  • Identify risk or potential quality issues and escalate / resolve.
  • Prepare and present quality data to analyse quality trends and support investigations and improvement initiatives.
  • Skills & Experience:
  • Minimum 3-5 years of quality assurance experience in medical device or related field.
  • Knowledge and experience of ISO 13485:2016 and European medical device requirements MDD 93/42/EEC and MDR (EU) 2017/745.
  • Competent in the use of quality management systems and associated documentation within a medical device or similar field.
  • Knowledge and experience in risk management ISO 14971
  • Auditing skills and experience.
  • Excellent attention to detail and accuracy
  • Excellent verbal and written communication skills
  • It is company policy as a matter of courtesy to respond to all applications within three working days. However because of the volume of applications we are currently receiving we are sometimes unable to respond to individual candidates. If we have not contacted you within three working days your application has been unsuccessful on this occasion and your details have not been retained. Please apply for any other position that you may see in the future. Required skills
  • Compliance
  • Medical Devices
  • Quality Assurance
  • QMS
  • ISO13485
  • Keyskills :
    Compliance Medical Devices Quality Assurance QMS ISO13485

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