QA Compliance & Audit Lead

ThermoFisher Scientific; Newport; On-site; GBP 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific in Newport is seeking an experienced QA/Regulatory professional to manage the ISO 9001 internal audit programme and liaise with Notified Bodies, MHRA, and customers on regulatory and technical issues.

You will coordinate external audits, ensure IVDR compliance, and oversee the batch release process and CAPA activities. A science/engineering degree with quality certifications and ISO13485 exposure is preferred.

Qualifications

• Honours degree in science or engineering required.
• Fully conversant in Word & Excel (Pivot tables).
• Six Sigma Green or Black Belt certification preferred.
• Experience in blow/injection moulding and extrusion advantageous.
• Formal quality qualifications (CQI Diploma, A11/A12 or MSc) preferred.
• Full/Chartered CQI membership advantageous.
• Proven experience managing internal audit programmes.
• Lead QMS auditor qualification advantageous.
• ISO13485 quality systems experience advantageous.

Responsibilities

• Manage the ISO 9001 internal audit programme, including auditor qualification and competency maintenance.
• Liaise with customers regarding regulatory, compliance and technical issues.
• Coordinate and lead external audit activities with customers.
• Ensure technical files are up to date and in full compliance with IVDR (EU) 2017/746.
• Liaise with Certification & Notified Bodies regarding ISO certification issues and CE marking of products.
• Liaise with MHRA and other authorities regarding IVDR regulatory compliance.
• Manage the customer complaints process with root cause analysis and corrective actions.
• Produce customer complaint reports and ensure timely responses.
• Train personnel in root cause analysis as required.
• Analyse complaint data and monitor trends for improvements.
• Produce monthly complaint KPI reports.
• Support maintenance of electronic quality systems to stay compliant.
• Provide oversight of Batch Release Team workload coordination and timely release.

Skills

Audit management

Regulatory compliance

MS Word & Excel

Quality tools (RCA, 5Y, 8D)

Quality tools (Pareto, Control Charts)

Education

Honours degree in science or engineering

Six Sigma Green/Black Belt

CQI Diploma / MSc in Quality

CQI membership (chartered) advantageous

ISO13485QA experience advantageous

Experience in blow/injection moulding and extrusion advantageous

Tools

MS Word

MS Excel (Pivot tables)

RCA

5Y

8D

C&E (Corrective & Effect)

Pareto charts

Control charts

Job description

Thermo Fisher Scientific in Newport is seeking an experienced QA/Regulatory professional to manage the ISO 9001 internal audit programme and liaise with Notified Bodies, MHRA, and customers on regulatory and technical issues.

You will coordinate external audits, ensure IVDR compliance, and oversee the batch release process and CAPA activities. A science/engineering degree with quality certifications and ISO13485 exposure is preferred.