QM Manager ISO13485

At PAICON we put healthcare first. We want to push the boundaries of the healthcare and diagnostic sector by harnessing the power of machine learning and cloud computing. We believe that digital health solutions will truly be an entirely new way to empower doctors and patients. That will be the key force behind the transformation of healthcare. We are excited to build on our vision with our enthusiastic team- which is the core of our company.

We are a startup where everyone has a place to put ideas on the table. Our PAICON mantra is to make an impact while you "grow" with our company!
In PAICON, "growth" | sparks with curiosity & passion | starts with initiative & innovation | prospers with teamwork & communication.

Tasks

• Supporting the management in the final set-up and implementation of the QM system (DIN ISO 13485 compliant quality management system)
• Ensuring compliance with standards and safety regulations of ISO (additional knowledge of FDA regulations is a plus)
• Maintaining, monitoring and reporting on the QM system. (e.g. management evaluation, document and record management, etc.)
• Documenting quality assurance activities and preparing reports
• Prepare and attend audits in conjunction with the PRRC
• Addressing and discussing problems and proposed solutions with supervisors
• Making recommendations for improvement in QM and MDR relevant areas

Requirements

• Completed studies in the natural sciences or a comparable degree
• First professional experience in quality assurance ideally DIN ISO 13485 and MDR
• Very good English and German language skills
• Analytical skills and independent, proactive working style

Benefits

What is waiting for you at PAICON:

• We are an open-minded and motivated team that collaborates to achieve innovation
• As an early-stage employee, you have plenty of room for growth and taking on responsibility
• Your efficiency should not be hampered due to lack of equipment- we provide you with all the necessities to show your full potential
• We also want to prioritize your personal and professional growth: let's define together your goals and development opportunities at PAICON
• Join us for a drink and spend quality time with the team - we believe innovative ideas are crafted best with joint efforts!

We are continuously expanding our benefits as we grow to ensure an environment where our team feels comfortable and excited to disrupt the healthcare and AI world.

As long as you have the eagerness to learn, grow and have the confidence that you can a make difference with and within PAICON we would be happy to hear from you even if you do not meet 100% of the requirements!

We are looking forward to getting to know you!