Supervisor, QA (Quality Systems Engineer)

Supervisor, QA role at Thermo Fisher Scientific overseeing quality systems, regulatory compliance, and customer complaints for medical device manufacturing. Manages ISO 9001 audits, IVDR compliance, and batch release operations in Newport.

Responsibilities

• Manage ISO 9001 internal audit programme, maintain auditor qualifications and competency
• Liaise with customers, Notified Bodies, and MHRA on regulatory and compliance matters
• Oversee customer complaints process including root cause analysis and corrective actions
• Maintain technical file compliance with IVDR regulations and CE marking requirements
• Provide functional oversight of Batch Release Team and produce monthly KPI reports

Requirements

• Honours degree in science or engineering
• Proven experience with MHRA and Notified Bodies on IVDR regulatory compliance
• Demonstrated expertise in quality tools: RCA, 5Y, 8D, C&E, Pareto analysis, control charts
• Previous role in medical device or IVD regulatory/compliance sector
• Proficiency in Microsoft Word and Excel, particularly pivot tables
• Experience managing internal audit programmes
• Lead QMS auditor qualification or ISO 13485 background preferred