Head of Quality Assurance
Head of Quality Assurance
Location; Canton St Gallen, Switzerland
·Fantastic Leader in Medical Technology who manufacture high-precision devices.
·Incredible opportunity to step into a medium sized organisation and form a crucial part of their team based in North East of Switzerland in the Canton of St Gallen.
·Beautifully located offices neighboured by the serene Lake Constance to the North and the striking Rhine Valley to the East.
The Head of Quality Assurance ensures that the quality requirements of IS013485, 21CFR820 and ANVISA are met and a permanent quality improvement takes place and the QM system is constantly evolving. The head of quality assurance controls the processes by checking the documents and / or products generated in the departments. As Head of Quality Assurance, you will arrange appropriate reviews by the departments as needed. The Head of Quality Assurance is responsible for controlling, evaluating and tracking triggered variance reports, change notifications, as well as releasing design and manufacturing documents for production operations.
The Head of Quality Assurance ensures that all production processes used are validated by the production process engineer or quality engineering or are regularly revalidated. They are responsible for the release of new processes validated by the process engineer or the quality engineering, or changes in the context of optimizations, new acquisitions or a design transfer of new products to manufacture
Direct Reports – Quality Control (3) Quality Technician (2)
·Professional and disciplinary leadership and planning of the two areas quality control and quality engineering
·Ensuring process reliability and a high-quality standard
·Further development of the quality assurance system and continuous improvement of processes under optimization of economic efficiency
·Ensuring the timely execution of all quality-related tasks, including in-process controls and QA approvals, especially in the area of goods delivery and production
·Test planning and evaluation of quality specifications, documentation of test-relevant data
·Ensuring the compatibility with and documentation of all activities in accordance with the relevant standards (eg ISO 13485, US 21 CFR 820 etc.) as well as in accordance with company instructions.
·Definition of key figures in consultation with GL, statistical processing of quality-relevant data and results
·Support of process owners in the design, introduction, documentation and control of production and organization processes
·Creation of error reports and follow-up of "corrective" and "preventive actions" as well as change notifications in the context of quality assurance as well as technical cooperation in interdisciplinary error channels and communication channels
·Preparation of and participation in internal system, process and product audits as well as external supplier audits in cooperation with Regulatory Affairs
·5 years of professional experience with leadership in Quality Assurance of Medical Devices
·Experience in Deviation and Change Management
·Experience in Application and Handling of statistical methods
·Experience in Manufacturing with metal parts and plastic parts
·Ideally, experience with the ERP system Microsoft Dynamics NAV2017
·Successfully completed studies of Medical / Human Biology / Engineering / Natural Sciences degree
Language Skills - German and English fluently