Quality Officer
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Working Pattern: 40 hours per week | Hybrid (2 days on-site, 3 days remote)
Overview
A leading medical device organisation is seeking a Quality Assurance Officer to support and maintain its Quality Management System while ensuring compliance with applicable regulatory and quality requirements.
This position offers the opportunity to work within a highly regulated environment, supporting quality operations across document control, CAPA management, audits, non-conformities and continuous improvement initiatives.
Key Responsibilities
- Manage quality documentation, ensuring accurate control, review and maintenance of quality records and procedures.
- Support the ongoing maintenance and improvement of the Quality Management System (QMS).
- Coordinate and follow up on Corrective and Preventive Actions (CAPAs), ensuring timely closure and effectiveness.
- Support internal and external audits, including preparation of documentation and follow-up of audit findings.
- Investigate non-conformities and quality issues, ensuring appropriate root cause analysis and corrective actions.
- Monitor compliance with internal quality procedures and applicable medical device quality standards.
- Collaborate with cross-functional teams to drive continuous improvement initiatives and strengthen quality processes.
- Assist in the preparation, review and implementation of quality documentation and procedures.
Requirements
- Experience within Quality Assurance in medical device industry
- Knowledge of Quality Management Systems and quality processes.
- Experience with CAPA management, document control and non-conformance handling.
- Familiarity with internal and external audit activities.
- Understanding of applicable quality and regulatory requirements, including ISO 13485 knowledge being advantageous.
- Strong organisational skills with excellent attention to detail.
- Ability to work independently while collaborating effectively with cross-functional teams.
What's on Offer
- Hybrid working model with flexibility.
- Opportunity to work within an innovative and regulated medical device environment.
- Exposure to a broad range of quality activities and continuous improvement projects.
- Collaborative and supportive team culture.
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