Quality Systems Coordinator – Medical Devices | ISO 13485

Pratap Partnership Ltd; Kirklees; Hybrid; GBP 32,000 - 46,000; Full time

Benefits offered by this job

Hybrid working model

Excellent benefits package

Job summary

Pratap Partnership Ltd is seeking a Quality Co-ordinator in a medical devices environment. The role supports the day-to-day operation of the Quality Management System, audits, CAPA, complaints, non-conformances, and regulatory quality support.

You will work closely with the Quality Assurance Manager in a hands-on capacity to drive continual improvement and maintain compliance across QMS activities, document control and quality metrics.

Qualifications

• Experience in a regulated quality environment, ideally medical devices.
• Working knowledge of ISO 13485.
• Experience with CAPA, internal audits, complaints and non-conformances.
• Document control and quality records management.

Responsibilities

• Coordinate day-to-day operation and continual improvement of the QMS.
• Coordinate risk-based internal audit programme, findings and corrective actions.
• Coordinate CAPA, complaints and non-conformances including root cause 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 risks.
• Support quality training and provide guidance to colleagues.

Skills

ISO 13485 exposure

Quality coordination

Regulatory quality

Education

Quality qualification or degree

Job description

Pratap Partnership Ltd is seeking a Quality Co-ordinator in a medical devices environment. The role supports the day-to-day operation of the Quality Management System, audits, CAPA, complaints, non-conformances, and regulatory quality support.

You will work closely with the Quality Assurance Manager in a hands-on capacity to drive continual improvement and maintain compliance across QMS activities, document control and quality metrics.