Senior Design Quality Assurance 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

As a Senior Design Quality Assurance Manager (digital products), 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:

Your Main Responsibilities:

• Represents Design Quality Assurance (DQA) in RIS R&D project teams to achieve sustainable compliance in projects for the assigned work area for digital products

• 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

• 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 documentation/deliverables during digital product development and product care activities

• 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

• Educates the business in quality topics in DQA Manager’s area of responsibility, by reiterating and emphasizing the importance and rationales for sustainable compliance

• Participates in the planning of design control deliverables and/or project team outputs

• Supports design and milestones reviews during product development and product care activities

• Supports external and internal audits and inspections as a subject matter expert within a particular area of focus

• Proactively gathers inputs and shares outputs of compliance related topics with other relevant Quality and Regulatory team members

• May coach colleagues and help others develop expertise/skills

• Navigates in complex situations by applying a diverse skill set

Additional tasks:

• 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.

• Is open minded and effectively communicates relevant Q-topics

• Demonstrates Roche Core Competences

• Acts as a proxy and supports other Product Quality Team Members

• Address conflict constructively in an atmosphere of openness and trust

• Drives decisions and innovative solutions which are effective and practical

• Is flexible and willing to adjust to multiple demands, shifting priorities and rapid changes

• Possesses effective negotiation and influencing skills

• Shows resilience stays focused and holds self-accountable for results

• Process and tool competency related to document management

Optional for employees to those it is applicable according to their position:

• 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.

• Responsible as the CAPA Task Owner for the correct and timely implementation of the assigned CAPA measures (tasks)

• Responsible as a PCQT Representative for Quality in the Product Care Team

Who You Are:

• Bachelor or Advanced degree in science, software engineering, or a related field.

• 5+ years of experience in the digital health industry or a related field within Quality Assurance

• Experienced in software quality engineering, quality assurance within regulated industries (medical device / in-vitro diagnostics / pharma)

• Technical expertise in software development and development tools

• Experienced in the implementation of enhancements of Design Controls, development methodologies, and tool capabilities

• Driven effective and correct implementation of the Risk Management process for medical devices during the entire product lifecycle

• Knowledge in digital health standards and regulations: FDA QSR, ISO 13485, 14971, IEC62304, 82304, 62366 and cybersecurity standards. 

• Track record of building and nurturing capabilities such as design, provision, and maintenance of software systems for document and data change control, product release, and complaint handling for digital health products.

• Experienced in working with software agile methodologies (SAFe, SCRUM, Kanban).

• Fluent English skills: can provide clarity regarding subtle differences, even when discussing complex matters.

Global Grade:

Please note that the global grade displayed is a target global grade for the role and the actual global grade offered to a candidate may vary depending on several factors - including scope and breadth of the role. For further information relating to global grading in Roche please visit the global grading gSite. Local regulations continue to apply.

Roche is an equal opportunity employer.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.