QA Engineer - Medical Devices | ISO 13485, CAPA & Audits

Elekta AB; Crawley; Hybrid; GBP 45,000 - 65,000; Full time

Benefits offered by this job

25 days holiday + bank holidays

Private Medical Insurance

Employer Pension Contribution

Job summary

Elekta AB is seeking a Quality Assurance Engineer to maintain and improve the Quality Management System, ensuring products meet high standards of quality, compliance and patient safety. You will work with Procurement, Supply Chain, Manufacturing, Regulatory Affairs and Logistics to drive improvements.

You’ll support audits, regulatory inspections, and translate requirements into practical business solutions across global teams.

Qualifications

• Degree in Engineering or equivalent industry experience.
• Experience in quality/regulatory roles in regulated industries, ideally medical devices.
• Knowledge of ISO 13485, MDR, IEC, QSR, MDSAP.
• Strong problem-solving with CAPA/Root Cause/Lean Six Sigma.

Responsibilities

• Lead quality and compliance activities to ensure projects are delivered.
• Monitor quality metrics, analyse trends, identify improvement opportunities.
• Act as Quality representative in CAPA, SCM, and Manufacturing processes.

Skills

Quality assurance

Regulatory compliance

CAPA

Root cause analysis

Lean Six Sigma

Cross-functional collaboration

Communication

Independent / team work

Education

Engineering degree

Engineering apprenticeship

Tools

CAPA system

Audit tools

Job description

Elekta AB is seeking a Quality Assurance Engineer to maintain and improve the Quality Management System, ensuring products meet high standards of quality, compliance and patient safety. You will work with Procurement, Supply Chain, Manufacturing, Regulatory Affairs and Logistics to drive improvements.

You’ll support audits, regulatory inspections, and translate requirements into practical business solutions across global teams.