Quality Engineer

About the role

The Quality Engineer will manage end‑to‑end quality for product families, from supplier selection through production transfer and lifecycle control. You will support quality activities, process validation, and continuous improvement in a hybrid work environment.

Key responsibilities

• Support quality‑related activities throughout transfer to production and ongoing manufacturing.
• Manage process validation and verification, including supplier guidance, planning, execution, monitoring, reporting and approval.
• Support change control activities and maintain robust production processes such as CTX cascading, monitoring tools, and PFMEA.
• Lead non‑conformance and CAPA investigations and drive improvement plans with suppliers.
• Contribute to production stabilization, trend analysis, process improvements and supplier guidance.

Required profile

• BSc or Practical Engineer in Engineering, Quality Assurance or related field; CQE, CQM or CQA qualification is a plus.
• Practical knowledge of ISO 13485 and experience in medical device electromechanics manufacturing.
• Demonstrated knowledge of manufacturing principles, practices and procedures.

Required skills

• ISO 13485
• Process validation
• PFMEA
• CAPA investigations
• Quality Management Systems (QMS)