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 growth
potential
- Nice colleagues, a great boss 😉, but even better customers 😊
- Attractive salary package 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
What we do
Ready to join us?
A true 'Amnovicus' can be recognized by the following values:
Act with integrity
We say what we do and we do what we say, and we do what is right.
Be proactive
We create and control situations, rather than responding to them.
Commit to quality
We create and control situations, rather than responding to them.
Think solution-oriented
We look at everything in terms of opportunities, not problems.
