Description
Manufacturing ExpertAn innovative Medical Device Company, based in the German part of Switzerland, are extend their manufacturing site. Therefore I am looking for a Manufacturing Expert, who could help establish the manufacturing site. As an expert in Sourcing and Production activities, you will be reporting directly to the Managing Director.
Requirements:
Must have:
- Experience in planning, realization and management of similar project such as (Greenfield, upgrade, extension of manufacturing)
- 10 years of experience in planning, realization and management of medical device manufacturing
- Strong experience with validation of manufacturing processes for medical devices
- Good knowledge of manufacturing regulations for medical devices EU /US & ISO 13485
- Expert knowledge of EU and Swiss safety and environmental regulations
- Experience of Project management, including process planning and developing
- Strong negotiation skills and good knowledge of local contracting processes·
- Excellent German skills, written and spoken (native speaker) & very good knowledge in English
- Higher education degree (FH, University)
- Experience with management and administration of all Procurement responsibilities.(contracting, purchase orders)
- Experience with basic chemical production processes and textiles
- Flexible and self-starter personality with high level of independence
- Ability to organize across all department levels from shop floor to top management
Responsibilities:
- Establish new medical device manufacturing facility, incl. Definition and Infrastructure planning of clean-room site
- Manage new adjoining distribution-center and laboratories
- Leading the Sourcing team on behalf of specifications for large production machines and equipment
- Define and Implement hygiene and work safety standards
- Plan and establish production processes and implement them to QM system.
- Set-up logistics for production value chain· Management of manufacturing process, including
- Work closely with Quality Management, Product Development, and Scientific Affairs to determine infrastructure and equipment specifications
- Manage and prioritize budget and according to management guidelines.
- Hiring of operating-staff, planning of shifts and ensure quality/hygiene standards are met
- Management of supplier base, administration of contracts, approval of supplier documents
- Management of equipment and production infrastructure
If this opportunity sounds interesting for you, or if you would like to get more information, please do not hesitate to contact me.
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