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.

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

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.

Click on Apply Now! 

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!

*** No Recruitment Agency, only direct applicants***