QA Engineer - GMP, CAPA & Process Optimization

Vulcain Engineering Group | Belgium; Vlaams-Brabant; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Company car

Meal vouchers

Sectorial bonus

Job summary

Vulcain Engineering Belgium in Leuven seeks a QA Engineer to join its team and support the QA Manager Production in ensuring products meet customer and regulatory requirements for both products and manufacturing processes.

You will contribute to maintaining product and process quality within the production environment, driven by control plans and a zero defects mindset, collaborating with production, maintenance and engineering to support continuous improvement initiatives and right-first-time

Qualifications

• Experience in pharmaceutical production or medical devices with QA
• Familiarity with GMP/QSR/ISO 13485 standards and CAPA processes
• Ability to train and coach operations staff on quality requirements

Responsibilities

• Support QA Manager Production to ensure customer and regulatory requirements are met
• Lead root-cause analysis and implement improvements in QMS, SOPs and control plans
• Coordinate audits and CAPA actions and verify effectiveness
• Provide GMP training and promote right-first-time on the shop floor
• Manage product complaints and ensure traceability and proper release

Skills

Communication

Stakeholder management

Analytical thinking

Problem solving

Attention to detail

Education

Higher scientific degree

Tools

GMP/HACCP knowledge

Job description

Vulcain Engineering Belgium in Leuven seeks a QA Engineer to join its team and support the QA Manager Production in ensuring products meet customer and regulatory requirements for both products and manufacturing processes.

You will contribute to maintaining product and process quality within the production environment, driven by control plans and a zero defects mindset, collaborating with production, maintenance and engineering to support continuous improvement initiatives and right-first-time