Senior Quality Engineer

About the role

We are looking for a Senior Quality Engineer to provide design quality engineering support, ensuring the delivery of high-quality products and new product introductions to our customers.

Key responsibilities

• Lead product development from a design-quality perspective, interpreting drawings, procedures and protocols.
• Identify, analyse and resolve complex quality exceptions and test results.
• Create and maintain risk documentation in line with ISO EN 14971.
• Support CAPA, NCEP, complaint analysis, field assessments, post-market surveillance and failure-mode investigations.
• Compile and analyse validation data, develop test methods, validation protocols and reports.
• Collaborate with R&D and suppliers to qualify new components, define statistical sampling plans and inspection methodologies.
• Apply Six Sigma, statistical analysis and Lean principles to drive continuous improvement.
• Provide technical guidance to team members and support internal and external audits.

Required profile

• Bachelor’s degree or higher in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.
• Several years of experience in design quality, risk management and product validation.
• Strong analytical mindset with the ability to interpret technical data and make decisions.
• Excellent teamwork and communication skills.

Required skills

• Risk Management (ISO EN 14971)
• Six Sigma, Lean and statistical analysis
• CAPA, NCEP, complaint analysis, field assessments, post-market surveillance
• Failure-mode and effects analysis (FMEA)
• Test method development, validation protocols and reporting
• Statistical sampling plans and inspection methodology
• Knowledge of internal and external audit processes