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Technical Supplier Manager

Elan Personal AG · Rotkreuz

New
Senior 🇬🇧 English
SPC Cp/Cpk MSA pFMEA IQ/OQ/PQ ISO 13485 GMP/FDA 8D Injection molding Electronics assembly

Job description

About the role

Elan Personal AG, acting for its long-standing client Roche Diagnostics International AG in Rotkreuz, is recruiting a Technical Supplier Manager for a temporary, full-time position. You will act as the technical interface between internal engineering and operations teams and international contract manufacturing partners, owning instrument components, subassemblies and production lines, with a focus on manufacturing process design, validation and industrialization. You will also lead E2E technology transfers, second-sourcing initiatives and capacity expansions.

Key responsibilities

  • Design, develop, optimize and industrialize manufacturing and testing processes for instrument components, electronics and precision assemblies at external supplier sites
  • Define and implement process validation strategies (IQ/OQ/PQ), design verification protocols and process capability assessments (Cp/Cpk, tolerance studies, Gage R&R)
  • Integrate DfX principles with R&D early in product development and mitigate manufacturing risks through pFMEA, poka-yoke and root-cause investigations
  • Lead E2E technology transfers, including production line relocations, tool duplications and second-source qualifications, and develop qualification master plans
  • Coordinate project schedules, report progress to MSAT and GIN leadership, and align change control with Roche Global Sourcing, Quality Assurance and Regulatory Affairs
  • Monitor supplier processes, KPIs and component quality, and lead technical investigations and SCARs using 8D, Ishikawa and 5-Why methods
  • Conduct supplier assessments and audits, and manage supplier-side engineering changes and capacity expansions

Required profile

  • Bachelor's or Master's degree or higher technical diploma in mechanical, electrical, mechatronics, process or industrial engineering or a related field
  • 5-6 years of experience in manufacturing process design, technical supplier management, industrialization or manufacturing engineering, preferably in medical devices, IVD, pharmaceuticals or precision high-tech equipment
  • Experience leading complex technical projects such as technology transfers, second-sourcing or production line ramp-ups; PMP, IPMA or Agile certification is an advantage
  • Professional fluency in English and German, written and spoken
  • Willingness to travel internationally about 20-30% for supplier reviews, audits and technology transfer milestones

Required skills

  • Hands-on experience designing, qualifying and optimizing manufacturing and testing processes
  • SPC, Cp/Cpk, MSA and pFMEA
  • Precision manufacturing technologies such as injection molding, precision mechanics and machining, electronics assembly and automated testing
  • Knowledge of ISO 13485, GMP/FDA regulations, process validation and change management

What we offer

  • A modern campus with green spaces and meeting areas, close to the motorway and a train station
  • Home office opportunities
  • Varied responsibilities and a dynamic team
  • Very good compensation

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Published 3 hours ago

Expires 1 month from now

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Elan Personal AG

Rotkreuz