Quality Systems Engineer - IVDR & ISO Compliance

Thermofisher Scientific; Newport; On-site; GBP 55,000 - 75,000; Full time

Job summary

Thermo Fisher Scientific in the United Kingdom is seeking a quality and regulatory professional to manage the ISO 9001 internal audit programme and coordinate external audits with customers. You will ensure IVDR compliance, liaise with MHRA and Notified Bodies, and maintain technical files.

The role requires an honours degree in science or engineering, Six Sigma certification, and proven experience in internal audit management. Experience in medical device/IVD regulatory environments is a plus.

Qualifications

• Honours degree in a science or engineering subject.
• Fully conversant in Microsoft Word & Excel (especially Pivot tables).
• Six Sigma Green or Black Belt certification preferred.
• Previous experience in blow/injection moulding and extrusion would be advantageous.
• Formal qualifications in quality e.g. CQI Diploma, A11, A12 or MSc preferred.
• Full member or Chartered member status of the Chartered Quality Institute would be advantageous.
• Proven experience of successfully managing internal audit programmes.
• Lead QMS auditor qualification would be advantageous.
• Background or experience working within ISO13485 Quality Management Systems would be advantageous.

Responsibilities

• Manage the ISO 9001 internal audit programme, including auditor qualification and competency maintenance, and conduct audits in line with the approved schedule
• Liaise with customers regarding regulatory, compliance and technical issues
• Coordinate and lead external audit activites 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 product
• Liaise with the MHRA and other Competent Authorities regarding regulatory compliance to IVDR
• Manage the customer complaints process, ensuring effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within agreed timescales
• Produce customer complaint reports and ensure customer complaint response times comply with company targets
• Train relevant personnel in root cause analysis as required
• Analyse complaint data and monitor trends to highlight further areas of improvement
• Produce monthly complaint KPI reports
• Support the ongoing maintenance and effective operation of electronic quality systems, ensuring systems remain compliant, current, and fit for purpose.
• Provide functional oversight of the Batch Release Team, supporting workload coordination, prioritisation and activities to ensure timely and compliant batch release.

Skills

Microsoft Word

Microsoft Excel

Six Sigma Green Belt

Six Sigma Black Belt

Internal audit

Regulatory compliance

QMS experience

Notified Bodies liaison

Education

Honours degree in science or engineering

CQI Diploma / MSc preferred

Chartered Quality Institute membership advantageous

Job description

Thermo Fisher Scientific in the United Kingdom is seeking a quality and regulatory professional to manage the ISO 9001 internal audit programme and coordinate external audits with customers. You will ensure IVDR compliance, liaise with MHRA and Notified Bodies, and maintain technical files.

The role requires an honours degree in science or engineering, Six Sigma certification, and proven experience in internal audit management. Experience in medical device/IVD regulatory environments is a plus.