APPLICATIONS
We only accept applications via https://www.amnovis.com/jobs
ABOUT AMNOVIS
Amnovis is an engineering and production company that uses innovative 3D printing technologies and materials to manufacture high-end products such as medical devices, high-tech, and thermal management applications. The company was founded in 2020 by a team of no-nonsense entrepreneurs and 3D printing experts with mainly two goals in mind:
1. make superior 3D printed products and provide excellent service to our customers
2. bring innovations in 3D printing technologies, materials and applications to the market
Are you ready to join us and redefine the state-of-the-art in 3D printing?
JOB DESCRIPTION
As quality manager you are the driving force behind Amnovis’ confidence in every part, and you ensure quality is not a separate process, but embedded in everything we do. Together with our quality engineer, you maintain our ISO13485:2016 certified quality management system, with the autonomy to continuously strengthen the robustness and reliability of our quality practices. You are the main point of contact for day-to-day quality assurance and regulatory affairs, to customers, suppliers, and colleagues. Additionally, you play a central, hands-on role in risk management, validation, and control activities of Amnovis’ production processes and customer products. Put simply, you are the core of Amnovis’ commitment to quality, and convey this mindset to everyone around you.
YOUR TASKS
- Defining and implementing improvements to Amnovis’ quality management system
- Leading Amnovis’ risk management activities
- Hosting audits for customers and certification bodies
- Stay up to date on the latest regulatory requirements applicable to Amnovis
- Managing distribution and timely completion of work between our quality engineer and yourself
YOUR RESPONSIBILITIES
- Own the Amnovis quality management system and the risk management process
- Maintain Amnovis’ ISO 13485:2016 certification
- Minimizing the occurrence of CAPAs, complaints and non-conformities, while ensuring timely handling when needed
- Support efficient and continued compliance as Amnovis’ business activities steadily increase
- Advocate a pragmatic and consistent approach to Amnovis’ commitment to quality across the entire organization
YOUR PROFILE
- You have a MSc in engineering or science, with 4 - 5 years of relevant experience. Specializations in life sciences, biomedical engineering, or manufacturing technologies are considered a plus.
- You have a proactive and structured approach to quality, and the drive to have a tangible impact
- You are a clear communicator, who can translate quality principles into practical actions for all stakeholders
- You have thorough working knowledge of ISO 13485:2016
- You have experience leading risk management activities
- You have demonstrated excellent documentation practices, attention to detail, and punctuality
- Professional proficiency in English, both written and spoken
- You are comfortable managing your own work, and guiding team members
- You can seamlessly switch between hands-on operational tasks and strategic thinking
- You have a no-nonsense entrepreneurial mindset
OUR OFFER
- A challenging job in a lean and mean scale-up company, with significant career development opportunities
- Nice colleagues, a great boss ;), but even better customers :)
- Attractive salary packages including extra-legal benefits
- No ping-pong or pool tables at Amnovis (yet), but we do have darts!
- Working location with excellent connectivity to public transportation
Job Types: Full-time, Permanent contract
Work Location: In person