Good knowledge of local document control systems and other relevant Quality processes and software applications
Good knowledge of the meaning of special characteristics; relevant standards, customer specific requirements and specifications
Good knowledge of product liability law and data protection
Working knowledge of MS-Office applications, ERP-QM skills and other relevant processes and documents
Understanding of continuous improvement and lean manufacturing principles
Personal competencies
Capacity to work both independently and in a team-oriented environment.
Ability to effectively complete the tasks entrusted.
Capacity to easily adapt to changing priorities and timelines.
Strong communication skills in English (oral and written).
Ability to learn quickly and attention to detail.
Optional competencies
Knowledge of international standards such as ISO 13485, ISO 9001, ISO 27001 or VDA 6.3.
Certified Lead Auditor preferred
CQE, CQM, CQA or other quality certification preferred
6 Sigma Black Belt certification preferred
Main Tasks
Creation of plant audit program (internal/external audits)
Performing internal audits according to plan and support 2nd/3rd party audits in the plant
Tracking of the closing progress of audit deviations in the plant based on an action plan and (if necessary) escalation of delays to planned closure
Alignment of plant activities with representatives of the GPO organization for new process roll outs or change management
Ensuring quality related documentation is controlled and archived, incl.
Information management in WIMS and other relevant Systems
Preparation of customer audits and tracking of customer notifications in relevant systems
Preparation, execution, and documentation of relevant training in cooperation with Plant HR (incl. process change management, auditor certification status etc.)