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