Quality Engineer

Overview

As a Quality Engineer, you will support product development, process validation, and quality improvements in a highly regulated medical device setting. You’ll collaborate with R&D, Manufacturing, and Quality to ensure compliance with ISO 13485, GMP, and other standards while driving safer, more reliable devices. Your work will influence design control, validation activities, and defect investigations, shaping product quality across the lifecycle. This role offers meaningful impact on patient safety and a culture of continuous improvement in a global team.

Retribuzione / Benefits Flexible working options

Medical insurance

Pension scheme

Employee stock purchase plan

Global recognition programme

Additional location-based benefits

Responsabilità Partner with R&D and Engineering to define product and process requirements

Support Design Control throughout the product development lifecycle

Review verification/validation plans, protocols, and reports

Review process validation activities for compliance

Lead change impact assessments and quality implications of changes

Coordinate investigations for verification/validation failures

Establish and maintain product quality control plans

Lead quality improvement initiatives in manufacturing operations

Analyze nonconforming products and support disposition decisions

Lead root cause investigations for production or customer-related failures

Manage CAPA activities and analyze quality trends

Support suppliers and external manufacturers with quality issues

Contribute to risk assessments and Health Hazard Assessments when required

Requisiti fondamentali Degree in Engineering, Chemistry, Biology, Physics, or another scientific discipline (educational background acceptable)

1–3 years of experience in Quality Assurance in Medical Device or Pharmaceutical industry

Experience supporting product design and development activities

Strong understanding of Product Development Processes and Design Control principles

Knowledge of ISO 13485 and Quality Management Systems

Understanding of GMP

Experience with validation activities, CAPA management, nonconformance investigations, and root cause analysis (strong advantage)

Strong analytical and problem-solving skills

Ability to work in cross-functional teams

Good communication and stakeholder management skills

Fluent in English (written and spoken)

Proficient in Microsoft Office Suite

problem-solving

cross-functional collaboration

stakeholder management

Design Control

Validation activities

CAPA management