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