Supervisor, QA (Quality Systems Engineer)

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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION

How you will make an impact:

• 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.

REQUIREMENTS

Minimum Requirements/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

Non-Negotiable Hiring Criteria

• Proven experience of dealing with Notified Bodies and the MHRA regarding regulatory compliance issues for IVDR

• Formal training, proven experience and success in the use of quality tools such as RCA, 5Y, 8D, C&E, Pareto, Control Charts etc.

• Previous experience in a regulatory or compliance role in the medical device/IVD sector

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.