Head of Supplier Quality Assurance
Class III - Active implantable Medical Devices – Company in significant growth
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 Head of Supplier Quality Assurance.
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 Quality Assurance and Regulatory Affairs department and will report to the Senior Director of Quality Assurance & Regulatory Affairs.
The Head of Supplier Quality Assurance is responsible for ensuring that subcontracted activities are under control and meet requirements of the main regulatory agencies (CE, FDA, KFDA, CFDA, PMDA, TGA, …).
Areas of responsibility:
- Leading the Supplier Quality Assurance Team (Allocation of resources, skills/competencies development of employees, hiring…)
- Ensure and maintain SQA processes following regulation ISO 13485 and FDA
- Support and participate to Product Quality Strategy projects
- Ensure quality in supplier’s deliveries together with team
- Established confidence in suppliers and their production processes using Production Part Approval Process
- Established Supplier assessment
- Assure competence development for own staff within area(s) of expertise.
- Monitor 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.
- Sign 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
- Suppliers Non-Conformities management
- Ensure continuous improvement of our suppliers
The profile we are looking for:
The right candidate has a scientific or technical background (degree) and possesses knowledge on regulatory requirements applicable to medical device in EU and US (ISO 13485 & 21CFR820), herein experience in supplier validation.
You will manage and structure a new team, why we expect you to have experience from managing professionals and higher-level project teams. Your capabilities and collaboration skills demonstrated ability to work effectively in cross-functional and/or global teams are important to succeed in the role.
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.
In your career, you have furthermore gained a good understanding of medical devices manufacturing and have experience in project management.
The essential skills for this position are responsiveness, communication, rigor, autonomy, 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.