Head of quality assurance

Employment rate: 20-40%
Starting date: as soon as possible

At ATANIS Biotech, we strive to make allergy diagnosis simple and safe for both patients and physicians.
Using cutting-edge technology, we have established a method to mimic allergic reactions in a test tube, keeping potentially harmful allergens away from the patient during diagnosis. All we require for the diagnostic work up is a small blood sample.
To assist our expansion, we are looking for an experienced Head of Quality Assurance with a strong background. We are looking for a Head of Quality Assurance to lead QA processes, support the team, and ensure regulatory compliance, including maintaining ISO 13485:2016 certification and obtaining ISO 15189 certification.

Main tasks & responsibilities 
- Build and maintain the Quality Management System (QMS) to meet ISO 13485, 21 CFR 820, CLIA, ISO 15189, and EU Regulation 2017/746 standards.
- Administer the eQMS system (Ennov) and support its expansion.
- Keep QMS documents organized and accessible.
- Align QMS with company goals.
- Help plan product releases and medical device development.
- Manage risks in production and QMS processes.
- Oversee validation of processes and equipment.
- Review and approve change controls.
- Handle quality issues, out of specifications, non-conformities, and complaints.
- Train and mentor staff on QMS, ISO 13485, ISO 15189, and QA processes.
- Share quality goals and report to senior management.
- Act as the main contact for regulatory authorities and suppliers on quality issues.
- Prepare for external audits and run internal ones.
- Check supplier quality, set up Quality Agreements, and handle corrective actions (SCAR).
- Track KPIs to improve processes and drive a culture of quality.
- Monitor medical devices in the market and plan for emergencies or recalls.

Your Profile 
Essential Technical Skills 
- Proven QA experience in a GMP-regulated environment, ideally in diagnostics or biotech, including a supervisory role
- Strong knowledge of ISO 13485 and ISO 14971 (Quality Management and Risk Management for medical devices)
- Familiarity with ISO 15189 (optional; quality and competence in medical laboratories)
- Experience managing audits, including internal audits
- Working understanding of regulatory frameworks relevant to diagnostic laboratories
- Previous working experience as Quality Assurance Manager.
- Solid understanding of scientific data collection and management methods.

Soft skills 
- Strong analytical and problem-solving skills
- Ability to work independently and manage priorities effectively
- Excellent communication skills (written and verbal)
- Collaborative mindset and enthusiasm for working in a dynamic, interdisciplinary start-up environment

Working Language: 
English C1 required;
French, or German is a plus

Education: 
Master’s degree in biology, life sciences, bioengineering, bioprocess engineering, biotechnology, pharmaceutical sciences, molecular biology, or similar.

Perks and Benefits 
- Profit sharing mechanisms (stock options; performance-based bonuses)
- Salary: up to 125 000 CHF – 100% yearly (can be discussed)
- Start-up environment with opportunities for rapid career development and acceleration.
- 25 days of vacation a year;
- Easily accessible location (Freiburgstrasse 251, 3018 Bern).

The application process 
If you feel attracted to this opportunity and you would like to take on new challenges, please send a CV to hr@atanis-biotech.com.
We will be in contact shortly thereafter to arrange for a first video call interview. This first interview will be followed by a second one on premises where you will get to meet the Team, after which we will make a hiring decision.