- Our company creates and distributes medical devices for almost 170 years; global and innovative solutions allowing everyone to become an actor of his own health.
- Operating in more than 86 countries through subsidiaries or distributors, our company (turnover of € 200 million, 2000 employees) has made innovation and patient comfort a priority.
SUMMARY OF DUTIES:
This position will be responsible for:
- Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for CFR 820/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, and SOPs. Including facilitating the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations and other applicable regulatory agencies.
- Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
- Manufacturing process development and qualifications, and problem solving/root cause analysis.
- Looking after the CE marking procedures (in connection with Emergo)
- Obtaining the ISO 13485 certification
- Maintenance of design files and drawing revisions of existing products, as well as any future products, by following standard operating procedures
- Interface with vendors on technical issues while supervising designs throughout the manufacturing process
- Support Design Control related activities and creation of other documentation
- Generate and analyze test data and reports to determine if designs meet functional and performance specifications
- Effectively interact with interdepartmental personnel and teams, such as marketing, purchasing, and manufacturing to uphold project plans and achieve project objectives
- Assist in the creation of inspection criteria
- Planning, organizing and supervising new Process Development
- Performs risk assessments (PFMEA) for new and existing processes
- Develops Process Validation Plans and protocols
- Manufacturing Process Maintenance and Improvement
- Troubleshooting and problem solving
- Identify and implement opportunities for continuous improvement
- Interact and coordinate activities with other departments, external vendors and customers
- As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support)
- Perform other Quality Systems related duties as required
- Preparation of Technical Files
- Conduct FDA facility registration
- Conduct CA. State medical device licensing process
- Educates the entire organization regarding compliance requirements
Socio-professional category (FR)
hours per week
Minimum level of education required
Minimum level of experience required