Quality Systems Co-ordinator

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

Quality Co-ordinator - 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 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.