Production & Installation Quality Engineer Drive Reliability

Normandy Hadrontherapy; Caen; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Normandy Hadrontherapy seeks a Production & Installation Quality Engineer to ensure parts and sub-assemblies meet internal and regulatory requirements for production and installation. You will support QMS, perform dimensional and documentary controls, and participate in audits (ISO 13485).

Collaboration with R&D, production and suppliers is essential to drive continuous improvement. The role requires reading technical drawings, applying FMEA, 8D, and PDCA methodologies, and communicating

Qualifications

• Engineering degree and industry quality/production experience.
• Knowledge of ISO 9001 and ISO 13485 standards.
• Experience with quality tools (8D, 5 whys, FMEA, PDCA).
• Ability to read technical drawings and customer specs.
• Internal audit experience preferred.

Responsabilités

• Draft/review production and installation procedures.
• Maintain the QMS (CAPA, indicators, etc.).
• Verify application of quality procedures in production/installation.
• Perform dimensional, functional, and documentary controls.
• Define verification and validation test plans per protocols.
• Address internal non-conformities with cross-functional teams.
• Monitor product/process changes and impact on tests.
• Participate in audits (ISO 13485 and others).
• Train staff on quality best practices.
• Draft/update quality documents (control plans, reports).
• Lead 8D, QRQC, FMEA for corrective actions.
• Propose continuous improvement initiatives.

Connaissances

Quality engineering

Dimensional control

Quality tools

ISO 9001 / ISO 13485

Internal audit

Drawing interpretation

ERP / MES

Cross-functional work

Formation

Engineering degree (Bac+5) in mechanical/quality/industrial production

Outils

CMM

Measuring instruments

ERP/MES

Description du poste

Normandy Hadrontherapy seeks a Production & Installation Quality Engineer to ensure parts and sub-assemblies meet internal and regulatory requirements for production and installation. You will support QMS, perform dimensional and documentary controls, and participate in audits (ISO 13485).

Collaboration with R&D, production and suppliers is essential to drive continuous improvement. The role requires reading technical drawings, applying FMEA, 8D, and PDCA methodologies, and communicating