Device Quality Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position This role is based in the Global Device Quality organization which has the end-to-end responsibility of leading and managing the quality aspects of developing and industrializing medical devices, drug-device combination products and packaging to deliver the pharmaceutical pipeline. We provide oversight for the development, industrialization, and continuous improvement of device-related quality processes and procedures as well as technical and compliance guidance considering the relevant standards and regulatory requirements for medical devices, combination products and packaging. We work closely with device development and device MSAT teams during development and manufacturing to ensure product integrity to design and manufacturing process specifications.  We leverage our external partners in order to offer flexibility and know-how to our internal capacity, at the right cost and quality. We enable our partners to reliably deliver compliant, quality products to our supply chain customers, so that we can meet the needs of patients worldwide.   We accomplish our mission through cross-functional collaboration focused on continuous improvement, embedding quality and reliability into the design, robust manufacturing, and ensuring quality process excellence.  The Opportunity As an integral part of Global Device Quality, you will collaborate with device development, device MSAT as well as device lifecycle teams and play an important role in a matrix organization to provide:  Subject Matter Expertise (SME) on design control, device industrialization, risk management, test method validation and statistical evaluations for device/combination products Quality engineering leadership/guidance to facilitate the intentional integration of quality and reliability into the design development as well as industrialization effort, thereby ensuring the development of design that is inherently of high quality and reliability Quality assurance oversight of internal partners and external GxP suppliers including CMOs to ensure compliance with regulations, standards and Roche requirements for the development, manufacturing, and post market quality oversight for medical devices and combination products Oversight of all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: method validations, Roche and Health Authority audits, complex investigations, complaint handling, and regulatory submissions, act as SME in Supplier Qualification and Maintenance audits Quality focused project management expertise by acting as the Quality Single Point of Contact (QSPOC) in device and packaging projects by liaising with internal and external partners, thereby ensuring cohesive and coordinated quality support for the development, manufacture and sustainment of devices and combination products Who you are You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies; where a job title is not considered the final definition of who you are, but the starting point. You have a Degree in an Engineering or Science discipline. You bring 4-6 years of experience in quality functions (device quality preferred) and relevant operational experience leading and/or working with internal and external teams through end-to-end projects. You have a thorough understanding of the biotechnology industry and specifically of combination products and medical devices. You have working knowledge of ISO 13485, 21 CFR 820, EU MDR and ISO You have a sound understanding of both Quality Compliance and Quality Engineering. Preferred: Ability to educate teams and organization on Design Controls as it applies to medical devices and combination products, and related topics Experience in industrialization, manufacturing and sustaining engineering of medical devices and device combination products including control strategy, PPQ strategy and design