Design Quality Partner

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

Who we are

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. 

The Opportunity:

We are hiring for a DQP to join our Product Development Quality operation to support software and hardware development of new medical devices.

As the Design Quality Partner, you will be responsible for ensuring effective partnerships within Q&R and related functions, enabling project acceleration by efficient and timely landmark achievement. You enable an efficient document review process by focusing on the output of the design control deliverables and balancing project workload across the customer areas through flexible workload allocation. You are an example of living collective success by working, believing and empowering each other.

Responsibilities:

Key Responsibilities to drive business results and customer value:

• Partner with SQP and applicable collaborators to ensure completeness and appropriateness of applicable achievement deliverables to ensure landmark readiness and achievement

• Review and approve achievement deliverables within development projects

• Represent Pre Market Quality in mQMS Communities and support internal and external audits

• Drive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other)

• Ensure timely execution and quality process management for design change requests, NCs and CAPA

• Models behavior to support and enable new ways of working and a culture of continuous improvement

Other Responsibilities to advance the work of the organization:

• Embed and continuously improve knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.

• Ensure effective change management in Product Development Quality, R&D and other functions

• Foster a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout Product Development Quality and other functions

• Serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.

• Drive decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementation.

• Serve as a coach, supporting colleagues to grow and develop their skills, fostering a learning and development-oriented environment

Who you are:

• Bachelor's degree in engineering, business administration or a related field and 3+ years experience or MBA or advanced degree is considered an advantage.

• Strong design control/mQMS understanding

• Knowledge and understanding of Quality and Regulatory requirements for review of design history file

• content

• Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, FDA, GMP, others)

• Technical writing and data interpretation skills, including ability to focus on the right degree of detail when reviewing deliverables

• Preferred experience in software and hardware for medical devices

Location: Sant Cugat del Vallès

Leadership Skills:

You are also responsible for building, and providing effective matrix-leadership for a global project team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. You will seek to inspire and lead your global team to create transformative solutions, and to influence their prioritization and uptake in the wider organization, in order to ensure that customer solutions are at the forefront of Pre Market Quality and deliver its optimal contribution to the Roche Diagnostics Vision.

The Design Quality Partner is expected to demonstrate the Roche Operating Principles and contribute to the Roche Group. The Roche Operating Principles are:
● 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.