Quality Administrator

Confidential; Huddersfield; Hybrid; GBP 35,000 - 55,000; Full time

Benefits offered by this job

Hybrid working model

Excellent benefits package

Job summary

Confidential is seeking a Quality Systems Co-ordinator in Huddersfield to support the day-to-day operation of its Quality Management System and broader quality activities. The role is hands-on, working with the Quality Assurance Manager to cover QMS coordination, internal audits, CAPA, complaints, non-conformances and regulatory quality support.

You will coordinate the day-to-day QMS, audit programmes, CAPA actions, document control and quality records, aiming to continually improve compliance

Qualifications

• Experience in a regulated quality environment, ideally medical devices.
• Working knowledge of ISO 13485 and related quality systems.
• CAPA, internal audits, complaints, non-conformances and document control.
• Strong organisation skills with ability to manage competing priorities.
• Ability to review information, identify gaps and escalate quality issues.
• Quality qualification or degree preferred; Auditor qualifications desirable.
• Experience supervising or coaching colleagues desirable.

Responsibilities

• Coordinate day-to-day operation and continual improvement of the QMS.
• Coordinate the internal audit programme and manage findings and CAPA actions.
• Coordinate CAPA, complaints, non-conformances and root-cause reviews.
• Manage document control, quality records and quality metrics.
• Support ISO 13485 and MDSAP compliance.
• Provide quality evidence and support to Regulatory Affairs.
• Coordinate supplier quality activity and monitor risk.
• Support quality training and guidance to colleagues.

Skills

Regulated quality environment

ISO 13485

CAPA

Internal audits

Document control

Organisational skills

Auditing qualification (Lead Auditor)

Supervising or coaching

Education

Quality qualification or degree

Job description

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.