Because sound matters!
Sound is a fundamental part of daily life that opens up a world of wonder. Sound and hearing are the key to human development and interaction. Sound is the way we understand, recognize and socialize with other people. In short, to hear is to live. Imagine a world without sound, without being able to hear, without being able to interact.
At Oticon Medical, LLC, we are passionate about using our combined expertise and resources to open up the world of sound to as many people as possible. Oticon Medical offers bone anchored hearing systems and cochlear implant solutions, which address the needs of different patient groups. Our solutions benefit people with hearing loss, specialized to meet the needs of those who face the hardest hearing challenges.
Oticon Medical, LLC acts as the US distributor for Oticon Medical AB. Oticon Medical, AB is the legal manufacturer of the implants and sound processors sold by Oticon Medical, LLC in the US. Oticon Medical, LLC and Oticon Medical AB are both wholly owned by William Demant Holdings.
Oticon Medical, LLC is looking for a Quality and Compliance Manager reporting into the President of the US Oticon Medical business. This role is to collaborate with global, local and functional partners to ensure quality compliance related to marketing, sales, support and distribution of implantable hearing solutions. Additional responsibilities in reporting product issues to the legal manufacturers and driving workforce compliance on training, process and procedures that are required for working in the highly regulated medical device industry are included in the role.
• Owner of the site quality system, establish and maintain efficient procedures in compliance with applicable regulations.
• Promote quality awareness throughout the organization (training, communication…).
• Provides quality and compliance oversight to operations ensuring compliance with company directives and governmental regulations.
• Host regulatory agency and third party inspections.
• Provides guidance on quality issues to the local teams.
• Ensure a close cooperation with the quality departments of the other WDH brands.
• Identifies core compliance requirements for staff; assigns training, policy review and reports on compliance activities
• Ensure product traceability to end user
• Manage product returns from the market.
• Manage the local complaint handling and market input processes to ensure that product related quality complaints are forwarded to legal manufacturers and help investigate product issues and adverse events.
• Escalates immediately to the supervisor, any issues impacting product quality or incidents in the field.
• Ensure regulatory compliance of locally developed sales promotion material
• Coordinate with US legal team on issues related to quality and legal compliance of the Oticon Medical, LLC business processes
• Minimum of 5 years’ experience in medical device or pharmaceutical quality and/or operations at a site level, including 2-4 years’ experience in a regulated function
• QA/QC experience preferred
• In-depth knowledge of cGMP regulations
• Organizational skills
• Effective and collaborative communication style
• Problem Solver