Device Assembly Quality Systems Expert e/v/e/r/y/o/n/e

Permanent employee, Full-time · Visp

About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your mission
We are seeking a Quality Systems Expert to support the build-up and operational readiness of our Quality Management System (QMS) for new device assembly capabilities in the area of combination products (e.g. autoinjectors, wearable injectors, needle safety devices). 
In this role, you will act as QMS process owner, ensuring regulatory compliance while actively contributing to the design, implementation, and continuous improvement of quality systems tailored to the evolving needs of device manufacturing.
This is a unique opportunity to shape the quality framework for the build-up of new, state-of-the-art device assembly line(s) in a highly regulated environment.
 
​Your responsibilities include,
  • Lead the roll-out and integration of the QMS for new device assembly operations, ensuring alignment with business and compliance needs. Ensure the QMS reflects all applicable regulations for combination products and device manufacturing (EU MDR, ISO 13485, EU GMP, FDA CFR Part 820/4)
  •  Actively drive compliance readiness as part of a cross-functional project team for the build-up of new device assembly capabilities – including support for validation, qualification, and documentation activities aligned with regulatory and operational requirements
  • Own and optimize core quality system processes (deviations, CAPAs, change control, training, documentation) with a dedicated focus on device assembly. 
  • Act as SME for eQMS tools like TrackWise to ensure system configuration and user readiness, while generating, monitoring, and communicating key QMS performance metrics (KPIs, quality reviews).
  • Lead preparation and coordination of audits and inspections, especially during ramp-up and launch of new device-related operations
  • Lead the GMP training strategy related to new device processes and systems Ensure the Quality Management System meets applicable regulations (EU GMP, FDA CFR, ISO 13485, ICH) for combination products
Your profile
We are looking for someone with, 
  • Master’s degree or equivalent in Life Sciences, Engineering, or a related scientific/technical discipline
  • Minimum 4 years’ experience in quality systems within pharmaceutical or medical device manufacturing, ideally with combination products or device assembly exposure
  • Hands-on experience with eQMS platforms (e.g., TrackWise), including system configuration and administration
  • Solid understanding of regulatory requirements for combination products and device manufacturing (e.g., EU MDR, ISO 13485, EU GMP, FDA 21 CFR Part 820/4)
  • Proven track record supporting audits and inspections from both health authorities and customers
  • Strong communication skills and ability to work collaboratively across functions such as QA, MSAT, Engineering, and Production
  • Fluent in English; German language skills are a strong advantage
  • Detail-oriented, analytical, and passionate about building and maintaining a robust, compliant quality system in a fast-evolving device assembly environment

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

Learn about ten23, https://www.youtube.com/watch?v=HgS3wd03JV0
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