Production & Installation Quality Engineer

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

Production & Installation Quality Engineer

The Production & Installation Quality Engineer ensures that parts and sub-assemblies comply with internal and regulatory requirements for production and installation.
They play a key role in the reliability of the production and installation of delivered, assembled, and installed products.

• Participate in drafting and/or reviewing production and installation procedures.
• Contribute to maintaining the QMS (processes, indicators, CAPA, etc.)
• Monitor and verify the application of all quality procedures in production and installation.
• Perform and supervise dimensional, functional, and documentary controls throughout the manufacturing process.
• Participate in defining verification and validation test plans, ensuring they are carried out in accordance with established protocols and regulatory requirements.
• Identify, analyze, and address internal non-conformities in collaboration with production, R&D, methods and industrialization, and supplier quality departments.
• Monitor changes to the product or manufacturing processes and assess their impact on verification and validation tests.
• Participate in internal and external audits (ISO 13485, certification bodies, etc.)
• Train and raise awareness among production department staff on quality best practices.
• Contribute to drafting and updating quality documents (control plans, procedures, checklists, inspection reports).

2 Associated responsibilities and scope of action

• Lead corrective and preventive actions within their scope (8D, QRQC, FMEA methodologies).
• Associated responsibilities and scope of action.
• Propose continuous improvement initiatives and contribute to optimizing quality processes.
• Write reports on quality performance, issues encountered, and actions taken, and communicate them to relevant stakeholders.
• Monitor quality indicators related to their area of activity.
• Alert management in the event of a malfunction.

3 Internal / external working relationships

• Reports to the Production & Installation Manager.
• NHa internal departments and certification bodies.

4 Specific professional knowledge

• Engineering degree (or equivalent Bac +5) in mechanical engineering, quality, or industrial production.
• Experience in quality control/production in industry (minimum 4 years / ideally special machinery, aeronautics, or automotive prototyping).
• Proficiency in quality tools and methods (8D, 5 whys, FMEA, PDCA).
• Good knowledge of technical processes (mechanical, electrical, assembly).
• Ability to read and interpret technical drawings and customer specifications.
• Good knowledge of ISO 9001 and ISO 13485 standards.
• Internal audit experience (not a prerequisite).
• In-depth knowledge of dimensional control (measuring instruments, CMM, gauges).
• Proficiency in IT tools and ERP/MES.
• Rigor, precision, autonomy, proactivity, and ability to propose solutions.
• Analytical and synthesis mindset.
• Ability to work cross-functionally.
• Strong interpersonal and communication skills.