Quality Affairs & Regulatory Affairs (ba_FR_OTM_QARA)
Exciting position in a successful medical device company based in Nice (Vallauris, in the south of France)
Do you want to contribute to the improvement of the life experience for people with a hearing disability?
Then we might have an exciting career for you as Supplier Quality Assurance Engineer.
Oticon Medical is committed to improve the quality of life of profoundly deaf patients. For that, we develop implantable medical devices and surgical techniques to restore profound hearing loss. As a member of Demant one of the world’s largest groups of hearing health care companies, we share a close link with Oticon and direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology.
In your new position, you will work closely with Purchasing, R&D and Industrialization departments. You will join the Supplier Quality department and will report to the Head of Supplier Quality Assurance.
Areas of responsabilities :
- Coordinate supplier process / part qualification using Production Part Approval Process and Contract review
- Coordinate Supplier assessment
- Participate during the product development phases to the supplier qualification.
- Manage the supplier quality process and documentation (VMP, Flowchart, DQ, IQ, OQ, PQ)
- Conduct audit at supplier and follow up on non-conformity found during audits.
- Manage Quality agreements with suppliers.
- Ensure Suppliers Surveillance process
- Ensure suppliers PFMEA management
- Manage Suppliers process changes (Change documentation, Product and process validation)
- Maintain the DMR of our suppliers
- Manage the Suppliers Non-Conformities and the Supplier Performance.
- Investigate root causes of non-conformities at suppliers and evaluation corrective action plans
- Ensure continuous improvement of our suppliers
The profile we are looking for:
- The right candidate has a scientific or technical background (degree) and is experienced in Supplier Quality Assurance in the Medical device field.
- You understand the technical specifications and protocols used to test the devices according to international standards. And you are strong in reviewing technical documents to ensure clarity, completeness, logic and structure.
- The essential skills for this position are communication, rigor, ability to analyze and summarize.
- Also, you write and speak English fluently.
What we offer:
The company is an exciting and challenging place to work and will offer you a great working atmosphere. It is a company in significant growth but is still an agile organization where decision paths are short, and the influence is high. As an individual, you will have the opportunity to make a big difference.
About Oticon Medical
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. We are part of the Demant Group - one of the world’s largest groups of hearing health care companies with more than 14,500 employees worldwide and revenues of over DKK 14 billion. We share a close link with Oticon and have direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. By working collaboratively with patients, physicians and hearing care professionals, we ensure that every solution we create is designed with user needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them. Because we know how much sound matters.