Quality Control Systems - Medical Devices
Hybrid working model plus excellent benefits package
Must have relevant industry experience of or exposure to ISO 13485.
An established medical device business is looking for a Quality Systems Co-ordinator to support the day-to-day operation of its Quality Management System and wider quality activity.
Working closely with the Quality Assurance Manager, this is a hands-on role covering QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support.
Key responsibilities
- Coordinate the day-to-day operation and continual improvement of the QMS
- Coordinate the risk-based internal audit programme, including findings and corrective actions
- Coordinate CAPA, complaints and non-conformances, including root cause and effectiveness reviews
- Manage document control, quality records and quality metrics
- Support compliance with ISO 13485 and MDSAP
- Provide quality evidence and support to Regulatory Affairs
- Coordinate supplier quality activity and monitor emerging quality risks
- Support quality training and provide practical guidance to colleagues
Experience required
- Practical experience in a regulated quality environment, ideally medical devices
- Working knowledge of ISO 13485
- Experience of CAPA, assisting in or preparing for internal audits, complaints, non-conformances and document control
- Strong organisation skills with the ability to manage competing priorities
- Confident reviewing information, identifying gaps and escalating quality issues
- Relevant quality qualification, degree or equivalent experience preferred
- Internal Auditor / Lead Auditor qualification desirable
- Experience supervising or coaching colleagues desirable
The opportunity
A broad quality role offering the opportunity to develop further experience across QMS, auditing, CAPA, complaints and regulatory compliance within a medical device environment.
#J-18808-Ljbffr
Quality Administrator in Huddersfield employer: Confidential
As a leading employer in the data centre operations sector, we offer an exceptional work environment that prioritises employee growth and development. Our collaborative culture fosters innovation and accountability, while our commitment to safety and operational excellence ensures that you will be part of a team that values your contributions. With opportunities for international travel and the chance to lead critical operations across the EMEA region, this role provides a unique platform for impactful leadership and career advancement.
