If you are a professional searching for a challenging job, with new opportunities and a chance for growth, then apply and become a member of our successful team!

 

We, SIS MEDICAL AG, a leading and fast growing innovative company in the field of minimally invasive coronary interventions are continuously looking for motivated professionals in order to provide best quality and top performing products to the market. 

 

 To strengthen our research and development department in Frauenfeld, we are looking for a solution-oriented and creative personality

Share with us the passion for excelling performance in the Medtech industry and forward your complete set of application documentation to:
This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  • Head Quality Assurance and Regulatory Affairs

    Zur Verstärkung unserer Qualitäts- und regulatorischen Abteilung in Frauenfeld suchen wir eine lösungsorientierte und erfahrene Persönlichkeit als

    Head Quality Assurance and Regulatory Affairs

    Ihre Aufgaben

    • Führung der QA/RA Abteilung
    • Q-Beauftragter und Berichterstattung ans Top-Management
    • Unterhalt und Pflege des Qualitätsmanagementsystem
    • Prozessverantwortung für Audits, Abweichungen, Beanstandungen, CAPAs.
    • Begleitung der Entwicklungsprojekte, Validierungen und Life Cycle Management der Produkte
    • Betreuung Risikomanagement
    • Sicherstellung der Post Market Surveillance
    • Verantwortlich für Regulatory Affairs, Vigilance System (incl. Incident reporting, FSN und FSCA)
    • Ansprechspartner für Notified Body, National Competent Authorities und Distributoren

    Ihr Profil

    • Technische Ausbildung, Fachhochschule oder Hochschulabschluss
    • Führungserfahrung
    • Prozessmanagement, Kenntnisse ISO 13485, 21CFR 820, MDD 93/42/EEC, MDR 2017/745/EU, MDSAP
    • Sehr gute Deutsch und Englischkenntnisse
    • Mindestens 5 Jahre Erfahrung in der Medizinaltechnik

    Es erwartet Sie eine von Kollegialität, Leistungs- und Hilfsbereitschaft geprägte Kultur in einem jungen, gut aufgestellten, innovativen Betrieb mit viel Pioniergeist. Neben herausfordernden und abwechslungsreichen Aufgaben in einem internationalen Umfeld bieten wir Ihnen verschiedene Weiterentwicklungsmöglichkeiten in unserem dynamischen und stark wachsenden Team. Teilen Sie mit uns die Leidenschaft für herausragende Leistungen in der Medizinal-technik, dann senden Sie bitte Ihre Bewerbungsunterlagen an: This email address is being protected from spambots. You need JavaScript enabled to view it.

  • Project Manager Medical Engineering

    To strengthen our research and development department in Frauenfeld, we are looking for a solution-oriented and creative personality

    Project Manager Medical Engineering

    Your tasks

    • Overall project management for coronary catheter development, as well as their packaging systems
    • Lead the development, analysis and optimization of design and processes for VI catheter systems from the idea to launch
    • Preparation of process and product development documentation
    • Assure quality, budget and timeline with external and internal partners

    Your profile

    • Natural science or technical basic education with further education as engineer with practical experience or university degree in the field of mechanical engineering, material technology or medical technology
    • At least 5-years experience in the field of process or design development, in the field of medical technology and plastics processing
    • Preferable at least 5-years experience in drug eluting balloon development and class III combination products
    • Experience with statistical software is an advantage
    • Fluent in German and English
    • Organizational and analytical skills
    • Strong, self-sufficient and team-capable personality, who works in a quality-conscious manner as well as solution-oriented and goal-oriented

    A culture of collegiality, efficiency and willingness to help is waiting for you in a young, well-established, innovative company with a great pioneering spirit. In addition to challenging and varied tasks in an international environment, we offer you various further development opportunities in our dynamic and rapidly growing team.

    If you share our passion for excellence in medical engineering, please send your application documents to: This email address is being protected from spambots. You need JavaScript enabled to view it.

  • Quality Assurance or Regulatory Affairs Specialist

    To strengthen our Quality Assurance and Regulatory Affairs Group in Frauenfeld, we are looking for a solution oriented and creative personality as

    Quality Assurance or Regulatory Affairs Specialist

    Your tasks

    • Worldwide registrations of class I and III medical devices
    • Assembly and maintenance of the worldwide registration documentation (STED, CSDT), provision of notarized and legalized documents
    • Collaboration with our distributors for submission in the respective countries
    • Assure seamless transition from MDD 93/42/EEC to MDR
    • Regulatory and quality projects (e.g. MDR, UDI) according to requirements in the target territories

    Your profile

    • Degree in technical or natural sciences or business administration background; at least Applied Sciences University level
    • 5 years of experience in medical device industry, in Regulatory Affairs, Design Assurance or Quality Assurance
    • Proficiency in MS Office applications
    • German and English orally and in writing: C2 level
    • Self-reliant, resilient, flexible, reliable, structured, sociable personality

    A culture of collegiality, efficiency and willingness to help is waiting for you in a young, well-established, innovative company with a great pioneering spirit. In addition to challenging and varied tasks in an international environment, we offer you various further development opportunities in our dynamic and rapidly growing team.

    If you share our passion for excellence in medical engineering, please send your application documents to: This email address is being protected from spambots. You need JavaScript enabled to view it.