Quality Affairs & Regulatory Affairs (ba_FR_OTM_QARA)
Are you ready to make a difference for people with a severe hearing disability and wearing sterile devices? Are you fueled by professional pride and skilled within the area of Sterility Process? Do you want to be part of developing new process compliance regarding sterilization activities during the manufacturing process? Then we might have an exciting opportunity for you as Sterility Assurance Manager at Oticon Medical.
Coordinate and manage sterilization activities (Ethylene Oxide and Steam sterilization) and clean room environments
The main tasks are:
- To defined sterilization strategy of new products
- To coordinate, review and approve annual sterilization validation/qualification reports
- To achieve the impact analysis of sterilization process following changes on products
- Daily follow-up of sterilization process and clean room environment activities including non-conformities, CAPA handling
- To follow trend analysis of the sterilization process
- To be the Interlocutor of project managers and regulatory authorities regarding sterilization activities
- To define protocols/ procedures for cleaning of manufacturing areas and provide specifications to the supplier.
- To perform supplier audits for sterilization activities
- To perform staff training on working in clean room area
- To release Batch after sterilization
- To ensure regulatory compliance regarding sterilization activities
- Biomedical, microbiology, pharmacy engineer (or similar)
- Real experience of controlled environments and cleaning / sterilization management in medical devices and/ or pharmaceutical industries or their external sub-contractors
- Subject matter expert on standards, regulation and Guidance (e.g.,ANSI, AAMI, EPA, EU, FDA, ISO, USP) related to the sterilization of Medical Devices such as ISO 11135-1, 11737-1&2, 14664, 17665-1, 10993-7, ANSI/AAMI TIR12, 14, 15, 16, 17, 19, 20, 28, 30, EN 550, 14161.
- Statistical skills required
- Technical writing skills required
- Abilities to work actively with multi-disciplinary team
- Rigorous, organized and self-managed
- We expect you to be fluent in French and English
We believe in the good life
Oticon Medical offers many challenges in an international organization full of energy and expertise. The right candidate will learn very much in a short time span, since you will have the opportunity to work with all aspects of clinical studies. Personal and professional development is the foundation for the growth of our business.
We create solutions that allow people to live their lives to the fullest. We also recognize in order to bring energy and inspiration to work, you need to re-energize and spend time with family, friends and hobbies in a healthy work life balance.
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.