A key client of mine who are a premier Swiss manufacturer and distributor of an MDR-certified generic system are currently looking for their new Head of QM/RA who has deep knowledge in the below functions, but also an attractive personality to bring a team together and success!
Your primary responsibilities include:
* Leadership and oversight of the QM/RA department, managing a small team of professionals.
* Administration of the quality management system in compliance with EN ISO 13485, MDR, FDA 820, and GMP standards. * Verification of medical device conformity, maintenance of technical documentation, market surveillance, and regulatory reporting.
* Upholding QMS adherence to EN ISO 13485, MDR, FDA 820, and GMP standards, ensuring compliance across all Medtech processes.
* Facilitating the effectiveness and sustainability of the QMS while managing authorities and certification audits.
* Execution of operational objectives, including deadlines, quality benchmarks, and cost-efficiency targets.
Your qualifications should ideally encompass:
* A minimum of five years of professional and managerial experience in QM within the medical technology sector.
* Proficiency in regulatory affairs within the medical technology industry.
* Strong familiarity with ISO 13485:2016 and EU MDR 2017/745.
* Demonstrated expertise in project and process management, coupled with a background in auditing.
* Analytical thinking coupled with a proactive, self-directed approach to work.
* Proficiency in verbal and written communication in both German and English
