Quality Systems Coordinator - Medical Devices (Hybrid)

Pratap Partnership Ltd; England; Hybrid; GBP 40,000 - 58,000; Full time

Job summary

Pratap Partnership Ltd in the United Kingdom is seeking a Quality Systems Co-ordinator to support the day-to-day operation of the Quality Management System and broader quality activities within a medical device environment.

The role involves hands-on QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support, reporting to the Quality Assurance Manager and collaborating across functions.

Qualifications

• Practical experience in a regulated quality environment, ideally medical devices.
• Working knowledge of ISO 13485.
• Experience with CAPA, internal audits, complaints, non-conformances and document control.
• Strong organisation skills with the ability to manage competing priorities.
• Ability to review information, identify gaps and escalate quality issues.

Responsibilities

• Coordinate day-to-day operation and continual improvement of the QMS.
• Coordinate 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.

Skills

ISO 13485

Internal Auditor

CAPA

Document control

Quality metrics

Education

Quality qualification or degree

Job description

Pratap Partnership Ltd in the United Kingdom is seeking a Quality Systems Co-ordinator to support the day-to-day operation of the Quality Management System and broader quality activities within a medical device environment.

The role involves hands-on QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support, reporting to the Quality Assurance Manager and collaborating across functions.