Quality Management Systems (QMS) Manager
Terapet SA, a Geneva based CERN MedTech start-up, is developing medical devices based on an
innovative technology for imaging in nuclear medicine to bring proton therapy to the next level.
We are looking for a motivated and proactive Quality Management Systems Manager (MDR) to join our
small, dynamic, and passionate team.
Role: Quality Systems Manager MDR
Start date – Duration: 01.01.2024 – Permanent (100%)
Place of work: Rue du Pré-Bouvier 7, CH-1242 Satigny
Responsibilities:
We are seeking a Quality Systems Manager to manage the Quality Systems function for a Medical
Devices fast-growing business. As the Quality Systems Manager, you will be responsible for ensuring
our products comply with all relevant regulatory requirements and standards.
- Set-up and maintain the in-house Quality Management System (QMS) for Medical Devices
in compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP, in collaboration with our
external QMS/QA advisor. - Oversee the implementation and maintenance of policies and procedures related to
quality management and control, including document control, change control, risk
management, supplier quality, and complaint handling. - Monitor and evaluate the effectiveness of the QMS through metrics and internal audits.
- Conduct external audits of suppliers and contract manufacturers to ensure compliance
with applicable regulatory requirements and quality standards. - Provide leadership and guidance to the Quality Systems team and cross-functional teams
to ensure quality objectives are met and maintained. - Ensure compliance with all applicable laws, regulations, and industry standards related to
Medical Devices. - Collaborate with Regulatory Affairs, R&D, Manufacturing, and other departments to ensure
quality requirements are incorporated into product development, production, and post-
market activities. - Write functional requirement documents and provide guidance on how to write them to
the other team members. - Participate in regulatory inspections and support resolution of any quality-related issues.
- Collaborate with other team members and stakeholders.
- Coordination with external collaborators.
Requirements:
- Bachelor’s or master’s degree in engineering, life sciences, regulatory affairs or a related
field. - Experience in the medical device field.
- Excellent communication and problem-solving skills. Strong attention to detail and ability
to prioritize tasks in fast paced environment. - Excellent analytical and multitasking skills.
- Good knowledge of English.
- Willingness to work in Geneva.
Preferred experience:
- Minimum of 2 years of experience in Quality Systems management within Medical Devices,
including knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820, and MDSAP. - Experience in conducting internal and external audits and supporting regulatory
inspections. - Notified body experience.
- LEAN or Agile certification.
- Expertise in C++, Java, or other programming languages.
If you want to know more about this job, please contact us on +41 76 339 9580.
This position will be filled as soon as a suitable candidate is found. If you are interested in this job
offer, please send your application (including cover letter and CV) to: Write an email