Design Quality Assurance Manager

As Design Quality Assurance Manager, you will ensure compliance of R&D processes, deliverables and documents to regulations, standards and good development practices.

Your tasks

• Be part of new product development and post-market engineering activities for Software and Hardware ensuring that quality assurance requirements are met
• Perform required Risk Management activities for Software and Hardware according to ISO 14971 and IEC 62304 in relation to assigned projects to ensure that the benefits of the product outweigh the risks
• Develop, maintain, monitor, and ensure the proper application of design and development control requirements to ensure compliance with applicable regulations
• Support project teams to ensure that products in the pipeline are launched according to project plan, minimizing process deviations
• Support design changes
• Proactively interact with development teams to identify and avoid deviations
• Establish a homogeneous understanding of needed procedures, processes, and approaches within the group R&D
• Align and harmonize processes in a growing R&D organization, eliminating redundancies and standardizing processes
• Support and initiate product improvements as necessary, particularly regarding reliability enhancements (., supporting FMEAs)
• Assist process owners with the creation and maintenance of SOPs (Standard Operating Procedures)
• Perform process improvements to enhance efficiency and effectiveness
• Support with open CAPAs (Corrective and Preventive Actions), Post Launch Changes, and NCs (Non-conformances) as required
• Support internal and external audits as needed

Your profile

• University degree in Engineering, Science, Quality and / or a related field of study
• 8+ years of experience in a regulated environment, preferably Medical Devices, in Quality, in positions of increasing responsibility supporting large, multi-site, global organizations
• Knowledge of ISO 13485, ISO 14971, IEC 62304, MDR 2017 / 745
• Experience with Software as a Medical Device (SaMD) and Software in Medical Device (SiMD) highly preferred
• Ability to give presentations to a wide spectrum of audiences
• Ability to understand, interpret and explain complex device quality regulations to non-experts
• Combination of strong technical background and business acumen
• Excellent interpersonal, communication and stakeholder management skills
• Proficiency in English, ensuring seamless communication within a diverse, global environment
• Good knowledge of the MS Office toolkit

Our offer

We can offer you a new challenge, with interesting tasks and much more including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.

Employment level : 100%.

Marcel Huber, Manager Talent Acquisition, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.