Mission & Job description
- Coordinate, control, and follow resources to manufacture company’s products according to schedules and quality policy
- Drive implementation of quality standards in terms of production and regulatory documentation follow up
- Be involved in R&D and V&V activities
- Perform and/or assist with gap assessments between regulatory requirements and QMS.
- Participate in Product and Process Qualification activities and establish the system, procedures, specification to ensure product quality meet the specified requirements.
- Compilation of technical dossiers, regulatory submissions for target markets
- Support Quality Manager in driving QMS process implementation and improvement.
- Work with Software or Technical Team to ensure sufficient documentation and standardization
- Participate in all aspects of medical device development activities such as:
- Development plans
- V&V tests
- Compliance to standards
- Production coordination
- Participate in QA audits
Required skills, education & experience
- Master’s degree biomedical engineering or equivalent.
- 5 years’ experience in medical device.
- Experience in CE and FDA (510(k)) certification process for electrical/electronic products
- Proficient in IEC 60601/ IEC 62366
- Knowledge in Quality System Regulation 21 CFR PART 820, ISO 13485
- Knowledge of Class II and III medical device technical file submission will be a bonus
- Soft skills: communication and technical writing
- Fluency in French and English at minimum
Are you ready to join our team?
Please send your CV to Edouard: firstname.lastname@example.org