Quality Manager

Vor 3 Tagen

Basel, Schweiz ARTIDIS Vollzeit

**About ARTIDIS**:
ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISnet digital platform, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes.

**Job Purpose**:
The Quality Manager will provide strategic and operational leadership to establish, improve, and maintain the quality systems, policies, standards, and procedures. The role is responsible for completing the implementation, maintaining and continuously improve the Quality Management System according to ISO 13485 of ARTIDIS AG.

Additionally, this role is responsible for managing the Quality System and associated compliance activities for the design, development, and manufacturing of medical devices in compliance with applicable quality and regulatory requirements. The Quality Manager reports to the Head of Quality Management.

**Duties and Responsibilities**:

- Supports the continuous improvement of the quality system regarding design, development, and manufacturing of products
- Responsible for audits and providing support for regulatory inspections
- Maintains oversight of quality documentation, including design and development records
- Ensure documents are thorough, accurate, and compliant to support regulatory inspections and submissions.
- Ensures budgets, schedules, and performance requirements are met
- Maintains a good working relationship with department supervisors, leads, subordinates, and peers.

**Qualifications**:

- Strong knowledge of the ISO 13485 Quality Management System environment over the entire spectrum
- Proven experience in an ISO 13485 quality-controlled environment
- Experience with Medical Device related Standards, internal and external Audits and Risk Management
- Excellent English skills (written and spoken)
- Team player, with a pragmatic approach and creative problem-solving capabilities
- Reliable, structured, and accurate way of working

**Working conditions**:
The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.

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