Design Quality Partner

1624 Roche Diagnostics S.L.; Sant Cugat del Vallès; On-site; EUR 70,000 - 90,000; Full time

Job summary

Roche is seeking a highly motivated Design Quality Partner to join our Product Development Quality organization. You will enable project acceleration, balance workload across customer areas, and ensure strong partnerships within Q&R while advancing a next-generation AI tool.

The role requires a proactive, agile professional with quality rigor and a tech-forward mindset. You will influence milestone readiness, ensure compliance, and drive continuous improvement across design change, NC, and CAPA

Qualifications

• Education: Bachelor’s degree in Engineering, Science, Business Administration, or related field.
• 3+ years in Quality Management Systems and design controls.
• Strong knowledge of ISO 13485, FDA, GMP requirements.
• Understanding of AI capabilities and related compliance.
• Excellent writing, data interpretation, and communication skills.
• Willing to travel internationally as needed.

Responsibilities

• Drive milestone readiness with cross-functional partners.
• Review and approve milestone deliverables in projects.
• Manage design changes, non-conformances, and CAPA processes.
• Drive standardization of deliverables across projects.
• Support audits and regulatory readiness.
• Lead and mentor junior team members.

Skills

QMS & design controls

Regulatory knowledge

AI awareness

Technical writing

Data interpretation

Communication

Collaboration

Facilitation

Education

Bachelor’s degree in Engineering/Science/Business

Job description

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

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action. We believe that good business means a better world. We are seeking a highly motivated Design Quality Partner (DQP) to join our Product Development Quality organization. In this role, you will be a key enabler of project acceleration, balancing workload across customer areas through flexible allocation and ensuring effective partnerships within Q&R. You will be an example of living collective success - working, trusting, and empowering each other while the team builds an ambitious, next-generation AI tool.

Your Impact

• Driving Business Results & Customer Value
• Milestone Readiness: Partner with Strategic Quality Partners (SQP) and cross-functional stakeholders to ensure the completeness and appropriateness of applicable milestone deliverables.
• Quality & Compliance: Review and approve milestone deliverables within development projects, acting as a Risk Enabler in decision-making.
• Process Excellence: Ensure timely execution and quality process management for design change requests, Non-Conformances (NC), and CAPA.
• Continuous Improvement: Reduce complexity and drive standardization of deliverables (templates, review processes, content) across all projects with pragmatic, agile solutions.
• Audit Readiness: Support internal and external regulatory audits.
• Advancing the Organization & Culture Knowledge Management: Embed and continuously improve knowledge sharing and retention within Pre-Market Quality.
• Change Management: Lead and support effective change management across Product Development Quality, R&D, and related functions.
• Matrix Leadership: Build, inspire, and provide effective matrix leadership for global project teams, ensuring customer solutions deliver optimal contribution to the Roche Diagnostics Vision.
• Coaching & Mentorship: Serve as a coach to support colleagues' growth, fostering a learning-oriented environment (especially crucial for guiding our junior team members).

Who you are

You are a proactive, agile professional who thinks in terms of impact and outcomes rather than tasks. You are comfortable in dynamic environments and possess a unique blend of quality rigor and a tech-forward mindset.

Qualifications & Experience

• Education: Bachelor’s degree in Engineering, Science, Business Administration, or a related field.
• Experience: 3+ years of experience in Quality Management Systems (QMS) and design controls.
• Regulatory Knowledge: Strong understanding of Quality and Regulatory requirements for reviewing Design History File (DHF) content (e.g., ISO 13485, FDA, GMP, or other heavily regulated industries).
• AI & Tech Savvy: A solid understanding or curiosity about AI capabilities and models is highly valued, as you will support tech-driven compliance initiatives.
• Skills: Exceptional technical writing, data interpretation, communication, collaboration, and facilitation skills.
• Mobility: Willingness to travel internationally depending upon business activities.

Our Operating Principles

As a DQP at Roche, you are expected to demonstrate and live our Operating Principles every day: Put patients first | Follow the science | Act as one team | Embrace differences Accelerate learning | Simplify radically | Make impact now | Think long term.

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. We believe it’s urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.