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German Speaking Change Manager

Posted on Sep 26, 2020 by Randstad (Schweiz) AG

Zug, Switzerland
Health Care
1 Nov 2020
Annual Salary

Main tasks:

Change Management:

Responsible for planning, coordinating and implementing changes in consultation with the product leader and/or team Leader

Implementation of assigned final reviews of changes to product:

Participation in regular planning/status meetings in consultation with the Product Leader

Technical assessment of change Requests

Technical assessment of the use of components and assemblies in the event of transport damage

Has in-depth knowledge of the assigned products

Creation and maintenance of specification and verification documents for product manufacture

Creation and maintenance of work plans, material master data and parts lists

Implementation of specification and verification document training for product manufacture as well as creation and coordination of the corresponding training evidence

Participation in the creation and revision of technical delivery conditions

Support of the Technical Supplier Management and production in troubleshooting and corrective measures

Participation in the definition and procurement or modification of operating and auxiliary materials

Ancillary tasks:

Quality management:

Support CAPA activities and process assigned tasks in the required quality and deadline.

Bears the responsibility for the qualitatively correct and targeted execution of all tasks assigned to him in compliance with the deadlines.

Compliance with the valid regulations, in particular with regard to occupational safety, GxP and ISO 13485

Technical review of verification/validation documentation

Maintenance of the Wiki knowledge database

Participation in regular team meeting

CIP/TOPinOPS (continuous improvement process):

Technical support of defined improvement measures and documentation in the change management

Bringing ideas to improve efficiency, safety, ergonomics in the entire working environment

Permanent optimization of workflows and processes to increase quality and efficiency

Active support in the implementation of improvement measures

Project work according to the allocation of must-haves:

At least HF degree or comparable technical qualification/Further training

At least 2 years of experience in change management, project and process management, preferably in medical technology

In-depth user knowledge in SAP or a comparable ERP system

Good User knowledge of common Windows and Google applications

At least 5 years of experience in the GxP environment, ideally in medical technology (ISO 13458, FDA 21, CFR 820)

Fluent in written and spoken German and English (documentation)

Teamwork, independent and reliable

Reference: 957497047

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