Quality Engineer H/F
Permanent Contract (CDI)
- Education: Msc. in Engineering or equivalent.
- Experiences: 3+ years of experience with a quality management system in the medical device industry.
- Desired experience: FDA regulated environment.
Quality Engineer H/F
The Quality Engineer will work under the responsibility of our Quality & Regulatory Affairs Manager to maintain and improve the Quality Management System according to ISO 13485: 2016 and other regulations associated with the medical device industry.
Our ideal candidate will have significant experience in developing and leading a Quality Management System in the medical device industry.
The role will evolve with the growth of the company and the various projects to come.
- Participate in the maintenance and improvement of the quality management system according to the standards in force: ISO 13485: 2016, 21CFR 820, 2017/745 MDR.
- Manage non-conformance processes, CAPA, management review and other data analysis activities for continuous improvement.
- Manage the document management activities of the quality management system.
- Develop, monitor, measure and communicate quality system performance indicators.
- Participate in raising awareness of Quality and the principle of continuous improvement among all staff through training activities.
- Contribute to the awareness of the teams on the requirements and to the preparation of internal and external audits and supplier audits.
Experience and Qualifications
- You have an engineering degree or equivalent.
- You have at least 3 years of significant experience with a quality management system.
- You are familiar with the ISO 13485 standard.
- You have experience in a CE regulated environment.
- You have experience in the medical device industry in a similar position in an FDA regulated environment.
- You are rigorous and organised and have a good sense of synthesis and analysis.
- You are able to communicate effectively and establish relationships with internal and external contacts.
- You have excellent organisational and communication skills.
- You have a strong team spirit.
- You have a good level of English (oral and written).
Working at Quantum Surgical means:
- Joining a talented, dynamic and multicultural team whilst being part of the technological and human adventure of a company in full evolution.
- Sharing our culture of innovation, team spirit and result-oriented
- Taking up technical challenges
- Benefiting from a competitive compensation (fixed salary+ variable, BSPCE)
Diversity is one of our strong beliefs. We therefore carefully study every application without any consideration that could be related to either physical or moral characteristics.
If you think you may be a good match
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