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Medical Device Quality Assurance Specialist

2 months ago

Aylesbury, Buckinghamshire, United Kingdom Newton Colmore Consulting Full time
Quality Assurance Role for Medical Devices

We are seeking a skilled Quality Assurance professional to join our team at Newton Colmore Consulting. As a Quality Assurance Manager for Medical Devices, you will play a crucial role in ensuring the quality and safety of our medical devices.

Key Responsibilities:

  • Implement and maintain a Quality Management System (QMS) in accordance with ISO 13485 standards
  • Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, and Software Engineers, to ensure quality and regulatory compliance
  • Conduct risk management, internal audits, and validation of medical devices
  • Develop and implement quality procedures and processes to ensure compliance with regulatory requirements

Requirements:

  • Relevant degree in a field related to Medical Devices or Quality Assurance
  • Experience in Quality Assurance for Medical Devices, with knowledge of ISO 13485 and 21 CFR Part 820
  • Strong analytical and problem-solving skills, with attention to detail
  • Excellent communication and collaboration skills

What We Offer:

  • A competitive salary and benefits package
  • A shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application.