Quality Assurance Specialist

Quality Assurance Specialist

Medical Devices / ISO13485 Quality Management Systems - Essential

Location: Heywood

Salary: depending on experience

PLEASE NOTE

To be considered for this position, you must have:

✔ Previous Quality Assurance experience within a Medical Device environment

AND/OR

✔ Significant experience working with ISO13485 Quality Management Systems

This is a documentation, compliance and quality systems role. It is not a laboratory, inspection, testing or hands-on Quality Control position.

Applicants without Medical Device and/or ISO13485 experience are unlikely to be considered.

The Role

Our client is seeking a Quality Assurance Specialist to support and continually improve their Quality Management System within a regulated Medical Device manufacturing environment.

This is a predominantly office-based role focused on:

• Quality Management Systems (QMS)
• ISO13485 compliance
• Internal auditing
• CAPA management
• Complaint investigations
• Documentation control
• Regulatory compliance
• Process improvement

The successful candidate will work closely with senior management and regulatory bodies to ensure ongoing compliance and quality excellence.

Key ResponsibilitiesQuality Management Systems

• Maintain and improve the company's Quality Management System (QMS)
• Develop, review and update quality procedures, policies and work instructions
• Identify gaps within existing quality systems and implement improvements
• Manage document control processes and quality documentation
• Support the maintenance of the electronic Quality Management System

Auditing & Compliance

• Coordinate and manage the internal audit programme
• Support external audits by regulatory and accreditation bodies
• Track audit findings and ensure agreed actions are completed
• Monitor compliance with ISO13485, ISO9001 and Medical Device regulatory requirements

CAPA, Complaints & Non-Conformances

• Investigate customer complaints and non-conformities
• Coordinate CAPA activities through to closure
• Monitor complaint and non-conformance trends
• Support root cause investigations and corrective actions

Regulatory Support

• Act as a key contact for quality and compliance matters
• Support communications with MHRA and Notified Bodies
• Assist with regulatory compliance activities and reporting

Supplier & Quality Administration

• Maintain approved supplier and contractor records
• Review supplier risk assessments
• Monitor calibration and service schedules
• Ensure product literature and artwork meet regulatory requirements

Experience Required

Essential

Previous experience in a Quality Assurance role

Medical Device industry experience and/or strong ISO13485 experience

Experience maintaining Quality Management Systems

Experience with internal audits

Experience managing CAPAs, complaints and non-conformances

Strong documentation and procedural writing skills

Desirable

Experience liaising with MHRA and/or Notified Bodies

ISO9001 experience

Lead Auditor qualification

Experience within a regulated manufacturing environment

Not Suitable For

This role is not focused on product inspection, laboratory testing or production-based quality control. Applicants whose experience is solely within Quality Inspection or Quality Control may not be suitable.

Please note that only shortlisted applicants will be contacted