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.
Design Quality Partner
Who We Are
At Roche were driven by one shared purpose to create a healthier future for everyone. We continuously advance science so that more people can access the healthcare they need today and for generations to come. Every innovation brings us closer to a world where we all have more time with the people we love.
Thats what makes us Roche.
The Opportunity
Are you passionate about driving quality collaboration and innovation in medical device development
Were looking for a Design Quality Partner (DQP) to join our Product Development Quality this role youll play a key part in bringing groundbreaking diagnostics to life supporting assay software hardware and instrument development projects.
As a trusted partner to cross-functional teams youll help ensure that every milestone is achieved with excellence that design control deliverables meet the highest standards and that we continuously improve how we work together.
This is your chance to make an impact accelerating innovation shaping quality practices and helping to deliver solutions that change lives.
What Youll Do
Youll be at the heart of our product development process ensuring quality is built in from the very start.
In this role you will:
Partner closely with project teams to ensure design control deliverables are complete and ready for key project milestones.
Review and approve development documentation ensuring accuracy clarity and compliance.
Drive standardisation across projects including templates processes and deliverable quality.
Support internal and external audits and represent Pre-Market Quality in mQMS communities.
Oversee design change requests non-conformances (NCs) and CAPAs ensuring timely and effective resolution.
Champion continuous improvement and new ways of working that make our teams stronger and more agile.
Youll also play a vital role in knowledge sharing change management and supporting your colleagues to learn and grow creating a culture where innovation thrives and success is shared.
Who You Are
Youre a collaborator a problem-solver and someone whos passionate about quality and impact. You build strong partnerships and love enabling teams to deliver their best work.
Youll bring:
Bachelors degree in engineering business administration or a related field and 3 years experience or MBA or advanced degree is considered an advantage.
Strong understanding of design control and medical Quality Management Systems (mQMS).
Knowledge of regulatory standards such as ISO 13485 FDA and GMP.
Experience reviewing design history files and other key quality deliverables.
Excellent communication and technical writing skills with an eye for detail and clarity.
If youre excited by the idea of enabling innovation improving processes and making healthcare better for patients everywhere wed love to hear from you.
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.