QMS Manager (50%)
Terapet SA
Veröffentlicht:
05 Dezember 2024Pensum:
50%Vertragsart:
Festanstellung- Arbeitsort:Geneva
QMS Manager (50%)
Terapet SA, a Geneva based CERN MedTech start-up, is developing medical devices based on an innovative technology for imaging in nuclear medicine to take proton therapy to the next level. We are looking for a motivated and detail-oriented QMS Manager to join our small, dynamic, and passionate team, for a 50% part-time position. Role: QMS manager
Start date - Duration: 01.02.2025 - Permanent (50%) Place of work: Rue du Pré-Bouvier 7, CH-1242 Satigny Responsibilities:
We are seeking a Quality Systems Manager to maintain the Quality Systems function for a fastgrowing medical device business, as well as to maintain the risk management for the products currently being developed. As the Quality Systems Manager, you will be responsible for:
- Experience in Quality Systems management for Medical Devices, including knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820, and MDSAP. - Experience in risk management in compliance with ISO 14971. 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: E-Mail schreiben
Terapet SA, a Geneva based CERN MedTech start-up, is developing medical devices based on an innovative technology for imaging in nuclear medicine to take proton therapy to the next level. We are looking for a motivated and detail-oriented QMS Manager to join our small, dynamic, and passionate team, for a 50% part-time position. Role: QMS manager
Start date - Duration: 01.02.2025 - Permanent (50%) Place of work: Rue du Pré-Bouvier 7, CH-1242 Satigny Responsibilities:
We are seeking a Quality Systems Manager to maintain the Quality Systems function for a fastgrowing medical device business, as well as to maintain the risk management for the products currently being developed. As the Quality Systems Manager, you will be responsible for:
- Maintenance of the Quality Management System,
- Risk Management of devices currently being developed,
- Managing the CAPA process, the Complaints process and the Document Control process,
- Support the Project Manager with quality aspects during Design and Development activities,
- Support the implementation and maintenance of policies and procedures related to manufacturing and sales activities,
- Support future extensions of the scope of the QMS, to include compliance with FDA CFR
- Participate in regulatory inspections and support resolution of any quality-related issues,
- Collaborate with other team members and stakeholders,
- Coordinate with external collaborators.
- Bachelor's or master's degree in engineering, life sciences, regulatory affairs or a related field.
- Work experience in a regulated field or industry.
- Excellent communication and problem-solving skills. Strong attention to detail and ability to prioritize tasks in a fast-paced environment.
- Excellent analytical and multitasking skills.
- Good knowledge of English.
- Willingness to work in Geneva
- Experience in Quality Systems management for Medical Devices, including knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820, and MDSAP. - Experience in risk management in compliance with ISO 14971. 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: E-Mail schreiben