QMS for Medical Devices and cutting-edge technologies, you will have a vital role in ensuring the efficient establishment and upkeep of the Quality Management System (QMS) throughout the organisation.
This position involves overseeing all aspects of quality management, including adherence to relevant regulations and standards.
Key Responsibilities:
Monitor and analyse quality metrics to identify areas for improvement and drive continuous
Develop, implement, and maintain the QMS in line with ISO 9001, ISO 13485, UK MDR 2002, and (EU) MDR 2017/745.
Ensure compliance with applicable regulations and standards, including FDA regulations, (EU) 2017/745, UK MDR 2002.
Lead internal audits, facilitate external audits, and ensure timely resolution of audit findings and corrective actions.
Required Skills, Knowledge, and Expertise:
Bachelor's degree in a relevant field (e.g., Engineering, Quality Management, Regulatory Affairs).
Minimum of 4 years of experience in quality management within the medical device industry
Familiarity with ISO Standards such as ISO 13485, ISO 9001, ISO 14971, IEC 62304, and EN 60601.
Detail-oriented mindset with a focus on continuous improvement and achieving results.
Certification in Quality Management or Auditing is advantageous.
Experience using tools like SharePoint, Confluence, and Jira.