Engineering supervisor állások, munkák minőségbiztosítás kategóriában

• Develop, modify, and maintain quality evaluation and control systems for materials, in-process parts, and finished products.
• Translate product requirements/specifications into test plans, methods, and fixtures to ensure product reliability.

Investigating and understanding the manufacturing processes and used raw materials, as well as troubleshooting issues and improving process efficiency....

• Lead and manage the site's full CAPEX portfolio, ensuring prioritization, regulatory compliance and alignment with corporate strategy.
• Lead, coach and develop a team of Project Managers and Controllers, ensuring effective resource planning and high performance.

• Start Date: 16 February 2026
• Latest Possible Start Date: 16 March 2026
• Planned Duration: 12 months
• Extension: Very likely (approved budget)
• Location: Rotkreuz
• Workload: 100%
• Home Office: Yes, less than 50%
• Team Size: 28 people
• Department: Design Control Excellence CH (DSRSPC)

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team, driving workpackage planning, implementation and resource allocation with line management...

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...