Quality Assurance and Compliance Lead

3 days ago


Oxford, Oxfordshire, United Kingdom Expert Employment Full time

Expert Employment is seeking a seasoned Quality Assurance and Compliance Lead to drive the effective implementation and maintenance of our Quality Management System (QMS). This critical role ensures compliance with relevant regulations and standards, guaranteeing the highest level of quality in our products and services.

As a key member of our team, you will be responsible for overseeing all aspects of quality management, including the creation, execution, and upkeep of our QMS following ISO 9001, ISO 13485, UK MDR 2002, and EU MDR 2017/745. This entails setting up and maintaining quality rules, steps, and paperwork to follow regulatory requirements, as well as overseeing tasks like Nonconformance Reports (NC), Corrective Actions (CAPA), and Change.

Responsibilities

  1. Develop and execute strategies for achieving and maintaining compliance with regulatory requirements.
  2. Collaborate with cross-functional teams to ensure quality considerations are incorporated into product development.
  3. Monitor changes in regulations and standards affecting our industry and implement necessary updates to the QMS.

Requirements

  • A bachelor's degree in a relevant field (Engineering, Quality Management, Regulatory Affairs).
  • Minimum of 3 years of experience in quality management within the medical device industry.
  • Familiarity with implementing and maintaining QMS in accordance with ISO standards.
  • Knowledge of ISO Standards, including ISO 13485, ISO 9001, ISO 14971, IEC 62304, and EN 60601.
  • Knowledge of global regulatory requirements applicable to our products and services.
  • Certification in Quality Management or Auditing is a plus.
  • Experience with tools like SharePoint, Confluence, and Jira.

Estimated Salary Range: $80,000 - $110,000 per annum, depending on experience and qualifications.



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