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Quality Systems Manager, tech company, Oxford
Client:
Expert Employment
Location:
Oxford, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
832898ee0470
Job Views:
4
Posted:
18.04.2025
Expiry Date:
02.06.2025
Job Description:
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:
1. Bachelor's degree in a relevant field (Engineering, Quality Management, Regulatory Affairs).
2. Minimum of 3 years of experience in quality management within the medical device industry.
3. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards.
4. Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304, and EN 60601.
5. Knowledge of global regulatory requirements applicable to the company's products and services.
6. Certification in Quality Management or Auditing is a plus.
7. Experience with tools like SharePoint, Confluence, and Jira.
Key Responsibilities:
1. Create, implement, and maintain the Quality Management System (QMS) following ISO 9001, ISO 13485, UK MDR 2002, and (EU) MDR 2017/745.
2. Lead internal audits, assist with external audits, and ensure issues found during audits are addressed promptly.
3. Establish and maintain quality procedures, processes, and documentation to comply with regulatory requirements.
4. Oversee QMS activities like Non-Conformance (NC), Corrective and Preventive Actions (CAPA), and Change Control.
5. Collaborate with cross-functional teams to incorporate quality considerations into product development.
6. Stay updated on changes in regulations and standards affecting the industry, ensuring timely updates to the QMS.
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