Senior Design Quality Assurance Manager

<p>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.</p><h3></h3><p></p><h3>The Position</h3><p><span>As a </span>Senior Design Quality Assurance Manager (digital products)<span>, you will play a critical role in maintaining the highest standards of quality and consistency in all design deliverables for the digital products developed by RIS (Roche Information Solutions). You will oversee the quality assurance process, ensuring compliance with medical device and IVD industry standards and regulations and Roche Quality Management System. In this role, you will:</span></p><p></p><p><b><b>Your Main Responsibilities:</b></b></p><ul><li><p><span>Represents Design Quality Assurance (DQA) in RIS R&amp;D project teams to achieve sustainable compliance in projects for the assigned work area for digital products</span></p></li><li><p><span>Has in-depth specialist knowledge of own job discipline and broad knowledge of related disciplines in the field. Managing compliance, documentation reviews, process implementation and/or contributes by participating in cross-functional or cross-chapter squads where it may take a leading role</span></p></li><li><p><span>Provides design control quality support with pro-active, business solutions oriented approach, while collaboratively being involved in the generation, review and approval of design control <span>documentation/deliverables</span> during digital product development and product care activities</span></p></li><li><p><span>Ensures that any design quality issues that may jeopardize the regulatory status of the projects and products in their work area are handled with the necessary priority and urgency</span></p></li><li><p><span>Educates the business in quality topics in DQA Manager’s area of responsibility, by reiterating and emphasizing the importance and rationales for sustainable compliance</span></p></li><li><p><span>Participates in the planning of design control deliverables and/or project team outputs</span></p></li><li><p><span>Supports design and milestones reviews during product development and product care activities</span></p></li><li><p><span>Supports external and internal audits and inspections as a subject matter expert within a particular area of focus</span></p></li><li><p><span>Proactively gathers inputs and shares outputs of compliance related topics with other relevant Quality and Regulatory team members</span></p></li><li><p><span>May coach colleagues and help others develop expertise/skills</span></p></li><li><p><span>Navigates in complex situations by applying a diverse skill set</span></p></li></ul><p></p><p>Additional tasks:</p><ul><li><p><span>Builds and maintains influential and effective relationships with key cross-functional stakeholders, with special focus on proactive communication and cultural awareness, enabling strategic quality related solutions, input and support.</span></p></li><li><p><span>Is open minded and effectively communicates relevant Q-topics</span></p></li><li><p><span>Demonstrates Roche Core Competences</span></p></li><li><p><span>Acts as a proxy and supports other Product Quality Team Members</span></p></li><li><p><span>Address conflict constructively in an atmosphere of openness and trust</span></p></li><li><p><span>Drives decisions and innovative solutions which are effective and practical</span></p></li><li><p><span>Is flexible and willing to adjust to multiple demands, shifting priorities and rapid changes</span></p></li><li><p><span>Possesses effective negotiation and influencing skills</span></p></li><li><p><span>Shows resilience stays focused and holds self-accountable for results</span></p></li><li><p><span>Process and tool competency related to document management</span></p></li></ul><p></p><p>Optional for employees to those it is applicable according to their position:</p><ul><li><p><span>Responsible as Process Advisor to ensure that a process is compliant to regulatory requirements and that good documentation proactive is considered in the process description.</span></p></li><li><p><span>Responsible as the CAPA Task Owner for the correct and timely implementation of the assigned CAPA measures (tasks)</span></p></li><li><p><span>Responsible as a PCQT Representative for Quality in the Product Care Team</span></p></li></ul><p></p><p><b><b>Who You Are:</b></b></p><ul><li><p><span>Bachelor or Advanced degree in science, software engineering, or a related field.</span></p></li><li><p><span>5+ years of experience in the digital health industry or a related field within Quality Assurance</span></p></li><li><p><span>Ex