Quality Affairs & Regulatory Affairs (ba_FR_OTM_QARA)
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 operations quality 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.
You will be part of our Quality team, which includes five engaged Quality Engineers reporting to the Quality Director. Our mission is to support the production in manufacturing products according to specifications, support in improving processes as well as the Quality Management System for being able to supply to class III Medical Device production.
Your main tasks will include:
- Daily shop floor walk
- Participate in operations meetings
- Lead nonconformities related to operations: coordinate functions/stakeholders, lead root cause analysis / problem solving, support to decision making on release or quarantine, coordinate and follow actions, assess effectiveness of actions until cloture
- Quality stakeholder or leader on projects related to manufacturing improvement
- Quality representative for design transfer to production of new product
- Follow the first manufacturing batch in production as part of design transfer activities
- Review qualification protocol and report as part of process validation
- Participate in trend analysis of production parameters/indicators
- Participate in answering notified body’s requests (request related to operations)
You can expect to get a wide variety of tasks and challenges, covering Quality and Compliance. You will get the chance to communicate and collaborate with many different stakeholders on different levels from experts in the development organization to our operators on the floor.
- You have a master’s degree in biomedical engineering or scientific area and have worked with manufacturing. We expect you to have a minimum of 5 years of work experience with Quality and Compliance in production - preferably within the medical device industry. Furthermore, we expect you to have strong experience with stakeholder management and quality management.
- Fluency in French is mandatory, and if you master English, it will be an important advantage.
As a person
- You have good interpersonal and communication skills
- You like to share information with your colleagues
- You are pragmatic and strive for efficiency in all that you do
- You are good at prioritizing between different tasks to achieve your own and our common goal
- You are able to work with analytical and structured work methods and you pay attention to detail.
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.