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Medical Devices Quality Assurance Specialist

2 months ago

Aylesbury, Buckinghamshire, United Kingdom Newton Colmore Consulting Ltd Full time
Quality Engineer Opportunity

We are seeking a highly skilled Quality Engineer to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:
  • Implement and maintain quality management systems (QMS) to meet ISO 13485 standards
  • Conduct risk management and internal audits to identify and mitigate potential risks
  • Collaborate with cross-functional teams to develop and implement quality procedures
  • Validate medical devices to ensure compliance with regulatory requirements
Requirements:
  • Degree in a relevant field, such as engineering or science
  • Experience in quality assurance and regulatory affairs for medical devices
  • Knowledge of ISO 13485 and 21 CFR Part 820 standards
  • Excellent communication and problem-solving skills
What We Offer:
  • Competitive salary and benefits package
  • Shares/equity scheme and pension plan
  • Private healthcare and income protection insurance
  • Employer discount scheme

We are an equal opportunities employer and welcome applications from candidates with varying levels of experience. If you are a motivated and detail-oriented individual with a passion for quality and safety, we encourage you to apply.