QA (QMS) Manager Medical Device Software - Switzerland
QA Manager and QMS lead for medical device software including web-based and mobile applications - French Switzerland
Our client is a Swiss based manufacturer of products relevant to both Pharmaceutical and Medical Devices markets. Based in the French speaking region, with good transport connections, they are seeking a QA manager to take responsibility for all QMS activities related to medical devices software, thus ensuring compliance to ISO 13485 as well as ISO 27001, and reporting directly to the Associate Director Device Quality System.
The role will furthermore encompass Documentation control, Training, supervision of the change control process, deviation and corrective actions, Supplier qualification, internal and external inspections, and serving as the primary contact for all computer system validation (CSV) matters
A typical background for such a position would be an Engineering diploma in information technology (security techniques, information security management or related matters), with additional training in IT systems compliance (data security, data integrity, regulatory) and several years experience in ensuring compliance of software development in the Medical Devices sector. Medical Devices experience is essential
English is the main language used on site, while French is a bonus as the local language.
This type of role does not come around every day. It's a large intrernational client with similarly promising career development prospects and renumeration. We're hoping to interview and place before Christmas, while longer notice periods will certainly be considered.
For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, or email him at firstname.lastname@example.org together with scanned certifications of training and Arbeits Zeugnisse.
For industry news and new opportunities in QA within the Swiss Medical Devices and Diagnostics sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en
KEY WORDS: QMS, Quality Management System, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, German, ISO 13485, ISO 9001, ISO 27001, GMP, Software, Computer Systems Validation, Medical Device jobs, Switzerland, Nonstop recruitment, Manufacturing, Engineering, process optimization
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