Device Quality Manager

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

This role is based in the Global Device Quality Management organization which has the end-to-end responsibility of leading and managing the quality aspects of developing medical devices, drug-device combination products and packaging to deliver the pharmaceutical pipeline. We provide oversight for the development, implementation, 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 lifecycle 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, and ensuring quality process excellence.

The Opportunity

As an integral part of Global Device Quality Management,you will collaborate with device and packaging development as well as device lifecycle teams and play an important role in a matrix organization to provide:

• Subject Matter Expertise (SME) on design control, 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 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 14971. 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

• Demonstrated capability of applying risk management concepts and tools

• Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing. Fluency in English is a must

• Demonstrated problem solving and decision making skills including hands-on working experience with quality-related tools, Six Sigma / DMAIC is preferred

• Experience in working in agile environment and usage of lean tools

This position requires up to 20% travel

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.