Join a global leader in health technology that is dedicated to improving lives through innovation and optimized manufacturing. You will connect quality management with all areas of the company, making sure our processes and continuous improvements meet the highest standards while supporting business goals.
Deine Aufgaben
- Maintain, develop, and improve the Quality Management System (QMS) according to ISO 13485 and regulatory requirements
- Act as the main contact for regulatory authorities, notified bodies, and internal teams on QMS topics
- Plan, coordinate, and lead internal and external audits; track and close CAPAs on time
- Prepare and present quality metrics, KPIs, and management review reports to senior leadership
- Work closely with R&D, Operations, Regulatory Affairs, and Commercial teams to include quality in all business processes
- Promote a culture of quality awareness through training, coaching, and clear communication
Was du mitbringst
- Bachelor’s degree in engineering, life sciences, or a related technical field
- 5+ years of quality management experience in the medical device or regulated healthcare industry
- Experience managing a QMS in line with ISO 13485
- Knowledge of FDA QSR (21 CFR Part 820) and EU Medical Device Regulation (MDR 2017/745) is a strong advantage
- Experience with audit management, CAPA processes, and regulatory submissions
- Fluent in English, written and spoken
- Knowledge of German and/or French is a plus
- Experience with Greenlight Guru eQMS is a plus
- Swiss work permit or European citizenship required
Was wir dir bieten
- Be part of a dynamic team in rapid growth
- Your work is visible and valued from day one
- Real ownership and chances to grow with the company
- Work on technologies that help treat vascular diseases and make a real difference in patients’ lives
Bist du Teil dieses Unternehmens?
Dieses Unternehmensprofil wurde automatisch erstellt. Wenn du für Acrostak (Schweiz) AG arbeitest, kannst du das Profil jetzt übernehmen und verifizieren – kostenlos und in wenigen Minuten.
Verifizierte Profile erhalten ein Siegel und können ihre Seite, Stellen und Bewerbungen direkt verwalten.
Über uns
Acrostak is a global health technology leader focused on innovation and quality to improve lives worldwide. We value teamwork, growth, and making a positive impact in healthcare.