Quality Systems Expert(m/w/x)

## Quality Systems Expert (d/f/m) 100% ###### Permanent employee, Full-time · Visp, Basel --- ##### Your mission We are looking for a passionate **Quality Systems Expert** to join our growing QA team. You'll be instrumental in shaping our quality framework and ensuring we consistently exceed industry standards. Your responsibilities will include: * Maintain adherence to legal, regulatory, internal company requirements, and international quality standards (e.g., EU GMP, CFR, ICH). * Guarantee the QMS reflects all legal obligations for medical device manufacturing. * Lead the development and ongoing management of the pharmaceutical quality system. * Facilitate customer audits and health authority inspections, managing all follow-up actions. * Act as the process owner for quality-related workflows within the QMS. * Generate and present key performance indicators for regular Quality Management Reviews. * Assist in the rollout of a new QMS, providing input from a user standpoint. * Support the efficient handling of documents, deviations, CAPAs, and change requests. * Serve as the subject matter expert for the Trackwise QMS system. * Drive enhancements to internal quality processes and manage eQMS administrative tasks. * Generate actionable insights through comprehensive KPI reporting and analysis. * Administer and optimize the eQMS platform, ensuring system integrity and user access. * Facilitate the seamless onboarding of new team members, fostering a culture of quality and compliance. ##### Your profile We are looking for someone with: * Master’s degree or equivalent in a science discipline * 4+ years’ experience in highly regulated pharmaceutical environment, preferably in Quality Systems. * Experience in personal interaction with customers and Health Authority interactions * Good communication skills * QA and manufacturing experience preferred * Business fluency in English is mandatory * Fluency in German a strong plus ##### Why us? We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential. Here's what sets ten23 apart: * A valuable and impactful career development opportunity in an inspiring environment * Flexible working arrangements and environment with an open culture and diverse workforce * The opportunity to work with and learn from highly qualified and experienced employees * Our learning and self-developing culture offers a wide range of training options * Competitive pension fund plan, annual bonus, and other financial and non-financial benefit At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws. \*\*\* No Recruitment Agency, only direct applicants\*\*\* ##### About us While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you! Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.