ISS AG, Integrated Scientific Services, is a leading Swiss service provider for the Medical Technology industry. We are a team of more than 50 engineers, scientists and medical experts who advise and support our customers in a growing industry. That is why we are gradually expanding our team and in the framework of our strategic development, we are currently looking for a committed person as
Senior Quality & Engineering Support in Medtech, 70–100 %
As a member of the Quality & Engineering supporting team, you will deal, among other things, with complex issues related to quality assurance. Depending on your field of expertise, you will be the contact person for special topics such as biocompatibility, toxicology or cybersecurity and you will support our customers in the corresponding projects.
- Establishment, maintenance and improvement of quality management system compliant processes for medical devices:
- Analysis of existing QMS to verify compliance with regulatory requirements,
- Digitisation and optimisation of existing QMS,
- Advice to our clients on the implementation of QMS processes,
- Advice and support to our customers during QMS audits or inspections and remediation projects,
- Support during internal audits,
- Advice, review, update or create technical documentation to comply with regulations and legal requirements (e.g. MDR/FDA, ...).
- Handling of complex quality support projects such as risk management; supplier quality; non-conformity management, including CAPAs and the definition and implementation of quality assurance strategies.
- Collaboration within interdisciplinary teams to solve problems in an integrated manner.
- Trainings and education at our clients' sites.
- Responsability for the professional development of junior staff.
- University degree or equivalent,
- You have at least five years of professional experience in the field of quality and engineering of medical devices, including ISO 13485, MDR/IVDR and FDA regulation.
- You have extensive experience in one or two special areas (e.g. complaints handling and FSCAs, toxicology, risk management, etc.).
- You are looking for a working environment with a focus on innovation and project variety.
- You want to understand complex contexts and are able to summarise and present them in an intelligible manner.
- You work accurately and reliably and have the necessary ambition and perseverance to achieve project goals,
- You are ready to support our clients on site for specific projects.
- You are a team player and service oriented (we work with high standards of professionalism, quality and scientificity).
- You speak French very well and have a very good command of written and spoken English. Other languages, especially German, are an advantage.
We offer you interesting and challenging work in an interdisciplinary team. You will have the opportunity to shape and develop your career in the growing and meaningful environment of medical technology. Your close contact with other ISS departments will open up many development opportunities and guarantee an exciting collaboration. Finally, you will benefit from a flexible working hours model and opportunities for further training. Due to our flexibility and depending on the configuration, we will also consider applications with lower employment percentages. Your place of work is in Geneva, home-office is possible.
We look forward to receiving your complete application by e-mail to the attention of Ms Sandra Item (Head of Compliance & Member of the Executive Board). If you have any questions, please do not hesitate to contact us.
We do not consider offers from recruitment agencies.