Supervisor, QA (Quality Systems Engineer)
Core
Manage ISO 9001 internal audit programmes, coordinate external audits, and oversee regulatory compliance (IVDR) for medical device/IVD products.
Role type
Senior Quality Systems Engineer (QA Supervisor)
Builds
Compliant medical device/IVD products and quality management systems
Domain
Medical Devices / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001 audit management, IVDR (EU) 2017/746 compliance, root cause analysis (RCA, 5Y, 8D), Notified Body liaison, MHRA regulatory compliance, batch release oversight, complaint management, KPI reporting, quality tools (Pareto, Control Charts)
Preferred skills
Six Sigma Green/Black Belt, CQI Diploma/A11/A12, Chartered Quality Institute membership, blow/injection moulding/extrusion experience, ISO 13485 experience
Technologies
Microsoft Word, Microsoft Excel (Pivot tables)
Responsibilities
Manage ISO 9001 internal audit programme and auditor qualification; Liaise with customers and Certification/Notified Bodies on regulatory and compliance issues; Manage customer complaints process including root cause analysis and corrective action plans; Produce monthly complaint KPI reports; Provide functional oversight of the Batch Release Team
Seniority
Senior, hands-on IC