Quality Lead

Pratap Partnership Ltd; Huddersfield; Hybride; GBP 35 000 - 48 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Pratap Partnership Ltd is seeking a Quality Control Officer - Medical Devices to support the day-to-day operation of the QMS in a hybrid role. You will work closely with the Quality Assurance Manager on QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support.

This hands-on position requires practical experience in a regulated quality environment, ideally in medical devices, with working knowledge of ISO 13485.

Qualifications

• Practical experience in a regulated quality environment, ideally medical devices.
• Working knowledge of ISO 13485.
• Experience of CAPA, audits, complaints, non-conformances and document control.
• Strong organisation skills and ability to prioritise.
• Internal Auditor/Lead Auditor qualification desirable.
• Experience supervising or coaching desirable.

Responsabilités

• Coordinate day-to-day operation and continual improvement of the QMS.
• Lead risk-based internal audit programme and drive corrective actions.
• Coordinate CAPA, complaints and non-conformances with root cause analysis.
• Manage document control, records and quality metrics.
• Support ISO 13485 and MDSAP compliance.
• Provide quality evidence and support to Regulatory Affairs.
• Coordinate supplier quality activity and monitor quality risks.
• Support quality training and guide colleagues.

Connaissances

ISO 13485

Internal audits

CAPA handling

Documentation

Regulatory support

Formation

Quality qualification or degree

Description du poste

Quality Control Officer - 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 Lead 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.