ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland, developing the first nanomechanical biomarker for cancer diagnosis and treatment optimization. ARTIDIS seeks to enable professionals to design personalized cancer treatment plans tailored to the individual patient’s needs and desired outcomes. The ARTIDISnet platform integrates many different clinical data types, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system.

Job purpose

The Senior Quality Systems Manager is responsible for completing the implementation and subsequently maintain the Quality System at ARTIDIS AG in the scope of ARTIDIS as legal manufacturer of a medical device. 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.

  • Develop and lead the quality management department in ARTIDIS and collaborate with R&D on the design, development, and manufacturing transfer of new or changed in-vitro medical devices.
  • Ensure appropriate application of company policies and procedures for medical device design controls, risk management, test method development, statistical data analysis, and regulatory filings support.
  • Lead the continuous improvement of the quality system elements that support the design, development, and manufacturing transfer of new products.
  • Maintain oversight of quality documentation, including but not limited to design and development records such as design history files, regulatory submissions, device master record, device history file, change control, validations, methods, and technology transfer.
  • Ensure documents are thorough, accurate, and compliant to support regulatory inspections and submissions.
  • Provide support for investigations and recommend, develop and implement corrective actions.
  • Provide support during regulatory inspections and audit and responsible for overseeing and/or performing auditing efforts that seek to ensure compliance with regulatory guidelines
  • Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
  • Proactively investigates, identifies and implements improved quality practices.
  • Ensures budgets, schedules, and performance requirements are met.
  • Judgement is required in resolving complex problems based on experience.
  • Maintain a good working relationship with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
  • Responsible for personnel actions including hiring, performance management, and termination.
  • Minimum of 5 years’ related experience required
  • Strong knowledge and background in medical device regulated environment required
  • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts and determines best course of action.
  • Prior experience in implementing a ISO 13485 Quality Management System over the entire spectrum of the standard.
  • Experience with Medical Device related Standards such as ISO 14971, ISO 62304, ISO 62366
  • Experience with internal and external auditing of Quality Systems
  • Experience in developing and managing various types of training initiatives
  • Positive attitude; values others and works well independently and in a team environment

The environment is a typical start-up with an intrinsically motivated international team. Our company is a great 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 highly meaningful purpose. The job position comes with a competitive salary and a bonus for outstanding performance.

Application contact

We look forward to receiving your online application with CV, motivation letter, and the names and addresses of 2–3 referees. Please, send your application by email to Brenda Marcus for first point of contact.