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
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
Suitable Backgrounds
We would particularly like to hear from candidates currently working as:
- Quality Assurance Specialist
- Quality Systems Specialist
- Quality Compliance Officer
- Quality & Regulatory Officer
- Quality Systems Coordinator
- QA Engineer (Medical Devices)
- Quality Manager (Medical Devices)
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
Pay: £40,000.00-£56,000.00 per year
Benefits:
- Company pension
- Free parking
- On-site parking
- Private medical insurance
Work Location: In person
