As a Quality Leader, you will implement and maintains ISO 13485 quality management systems, create and maintain all quality processes/documentation, ensure compliance of personnel to the QMS through coaching and training, fulfill customers’ requirements on quality issues and work closely with the management team in fulfilling all of the above

Job Description

  • Act as primary quality representative for existing and prospective customers
  • Oversee and maintain compliance with MDR 2017/745/EU, ISO 13485 and USA 21 CFR part 820
  • Review and consolidate product requirements for medical device systems developed at EBAMed according to applicable regulations
  • Contribute actively to defining medical device documentation, from user needs and applicable standards, to design verification testing, and give appropriate guidance to the development teams
  • Work closely with Clinical Affairs to set up quality files suitable for submission to pre-market clinical investigation as required by Competent Authorities
  • Work in collaboration with the Legal team to prepare manufacturing and quality agreements with external providers and suppliers
  • Work effectively in close collaboration with external providers or suppliers and perform quality audits
  • Create and maintain all quality documentation related to products, including product test protocols, change management and notification processes, corrective and preventative actions (CAPA), customer complaints, audits and related items
  • Train and coach EBAMed teams to use, follow and work under QA Processes along the projects
  • Oversee the risk management process and oversee its related activities
  • Act as the main source of quality and regulatory knowledge and strategy within EBAMed
  • Report to management on quality issues, trends and effectiveness.

 

Contact
Marina Izzo, CEO EBAMed
  • Marina.izzo@eba-med.com

Required profile

Profile

  • MS in Engineering or relevant Life Science discipline with 5+years of experience in a similar position in the medical device industry (preferably with class III medical devices)
  • Detailed understanding of the EU, Swiss and USA medical device regulations, including the MDR 2017/745/EU, the FDA 21 CFR Part 820 and ISO 13485 requirements
  • Experience with setting-up and maintenance of Quality Management Systems and Processes for Medical Devices
  • Demonstrated skills in risk management (ISO 14971) and documentation compliant with standards and guidelines of the medical device industry (e.g., technical documentation, design history file, Investigational Device Exemption)
  • Experience and/or specialization in one or more of the following areas:
  • Active implantable medical devices – ISO 14708 series
  • Medical electrical devices – IEC 60601 series
  • Software as a Medical Device – IEC 62304
  • Medical device usability engineering – IEC 62366
  • Experience managing a small team of QA Engineers
  • Strong organizational and communication skills, including ability to communicate with academic scientists and internal clinical teams
  • Successfully stay within defined budgets and schedules
  • Work independently and within a team
  • Possess a positive, “can-do” attitude
  • Strong at taking initiative, fast learner
  • Attention to details
  • Fluency in written and oral English.

Workplace: Campus Biotech Innovation Park, Geneva (Switzerland)

Activity rate: 100% – can start at a lower percentage in a transition phase

Eligibility: Swiss work permit / EU nationality

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