Vice President Quality

vor 2 Wochen

Port BE, Bern, Schweiz Ziemer Group Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

Tasks

  • Strategic and operational management of quality management and regulatory affairs
  • Responsibility for the further development and audit security of the quality management system (including MDSAP)
  • Operational implementation of internal audits and supplier audits in accordance with ISO 13485, MDR, and MDSAP
  • Assumption of the role of Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR
  • Management of approval processes and communication with notified bodies and authorities
  • Ensuring product conformity and product approval
  • Leadership, promotion, and further development of subordinate teams
  • Close cooperation with the CEO, management, and internal stakeholders

Profile

  • University degree (engineering), ideally supplemented by further training in quality management and/or regulatory affairs
  • Several years of management experience in the Medtech field, in the areas of quality and regulatory affairs
  • Operational experience and enjoyment of conducting audits
  • Comprehensive knowledge of relevant standards and regulations, especially ISO 13485, FDA 21 CFR 820, EU-MDR
  • In-depth knowledge of validation (including sterile products), statistical methods, SW off-the-shelf validation, cybersecurity
  • Business fluent in German and English, other languages an advantage
  • Assertive, integrative leadership personality with high intercultural competence
  • High resilience, solution-oriented and enjoys working with others at all levels

We offer you an exciting challenge in the growth-oriented medical technology market. As a committed and proactive personality, you can help shape the future of our dynamic company. Have we aroused your interest? Then we look forward to receiving your complete online application.

For further information, please contact Mr. Richard Büchi, Director Human Resources,

If you have any technical questions, please contact the current position holder, Dr. Hartmut Kanngiesser, Vice President Quality Management & Regulatory Affairs,

Ziemer Ophthalmic Systems AG

Allmendstrasse 11

CH-2562 Port, Switzerland

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