As QMS Manager, you will be instrumental in ensuring the effective implementation and maintenance of the Quality Management System across the organisation.
You will oversee all aspects of quality management, ensuring compliance with relevant regulations and standards.
Key skills and experience:
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.
Experience with implementing and maintaining Quality Management Systems (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 the company's products and services
Certification in Quality Management or Auditing is a plus.
Experience with tools like SharePoint, Confluence, and Jira
Key responsibilities:
Create, put into action, and keep up the Quality Management System (QMS) following ISO 9001, ISO 13485, UK MDR 2002, and (EU) MDR 2017/745.
Lead internal checks, help with external checks, and make sure issues found during checks are quickly fixed.
Set up and maintain quality rules, steps, and paperwork to follow regulatory rules.
Oversee QMS tasks like NC, CAPA, and Change.
Work with teams from different departments to include quality concerns into the making of products.
Stay updated about changes in rules and standards that affect our industry, and make sure any needed changes to the QMS are done on time.