Global Supplier Process Design Lead

Flexsis AG, Filiale Basel LS; Rotkreuz; Presencial; CHF 120.000 - 180.000; Jornada completa

Descripción de la vacante

Flexsis AG is seeking a reliable Technical Supplier Manager for Roche Diagnostics in Rotkreuz. The role focuses on designing, validating, and optimizing manufacturing and testing processes for instrument components across the supplier base, with emphasis on DfX and process capability.

Responsibilities include leading PFMEA, quality controls, and root-cause investigations, while collaborating with R&D to prevent bottlenecks and drive yield improvements. Travel globally approx. 20–30% is required.

Formación

• University degree in a technical field (Mechanical, Electrical, Mechatronics, Process/Industrial Engineering).
• 5-6+ years in manufacturing process design, supplier management, industrialization, or manufacturing engineering; medical devices/IVD/pharma/precision high-tech preferred.
• Proven hands-on experience in designing, qualifying, and optimizing manufacturing and test processes with SPC, Cpk, MSA, and pFMEA.
• Knowledge of ISO 13485, GMP/FDA, IQ/OQ/PQ, and change control procedures.
• Pragmatic problem solver with strong intercultural communication and stakeholder management.
• English and German proficiency; willingness to travel globally (20–30%).

Responsabilidades

• Design, optimize, and industrialize manufacturing and testing processes for instrument components and assemblies across the external supply base.
• Define process validation strategies (IQ/OQ/PQ), verification protocols, and process capability baselines (Cp/Cpk, tolerance studies, Gage R&R).
• Partner with R&D to embed DfX principles early in development to prevent bottlenecks and improve yield.
• Lead PFMEA, establish poka-yoke controls, and drive root-cause investigations to mitigate process vulnerabilities.
• Monitor supplier process stability, KPIs, and component quality trends throughout the lifecycle.

Conocimientos

Process design

SPC

Cpk

MSA

pFMEA

Design for Manufacturing (DfX)

Change management

Stakeholder management

Quality standards awareness

Educación

Bachelor's, Master's or Higher Technical Diploma in Mechanical/Electrical/Mechatronics/Process/Industrial Engineering

Descripción del empleo

Flexsis AG is seeking a reliable Technical Supplier Manager for Roche Diagnostics in Rotkreuz. The role focuses on designing, validating, and optimizing manufacturing and testing processes for instrument components across the supplier base, with emphasis on DfX and process capability.

Responsibilities include leading PFMEA, quality controls, and root-cause investigations, while collaborating with R&D to prevent bottlenecks and drive yield improvements. Travel globally approx. 20–30% is required.