Design Quality Partner (mwd)
Job Location:
Ludwigsburg - Germany
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
We are seeking a highly motivated Design Quality Partner (DQP) to join our Product Development Quality 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 successworking trusting and empowering each other while the team builds an ambitious next-generation AI tool.
Milestone Governance & Risk Management: Partner with Strategic Quality Partners (SQP) and cross-functional stakeholders to review approve and ensure the completeness of milestone deliverables acting as a pragmatic Risk Enabler in decision-making.
Process Excellence & Audit Readiness: Oversee the timely execution and quality management of design change requests Non-Conformances (NC) and CAPA while actively supporting internal and external regulatory audits.
Continuous Improvement & Change Leadership: Lead effective change management across R&D and Quality functions to reduce complexity drive standardization of deliverables (templates processes) and implement agile solutions.
Matrix Leadership & Vision Alignment: Build inspire and provide effective matrix leadership for global project teams ensuring customer solutions deliver optimal contribution to the Roche Diagnostics Vision.
Coaching Mentorship & Knowledge Management: Foster a learning-oriented environment by coaching colleaguesespecially junior team membersand embedding continuous knowledge sharing and retention practices within Pre-Market Quality.
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.
Education: Bachelors degree in Engineering Science Business Administration or a related field.
Experience: 3 years of professional experience working with Quality Management Systems (QMS) and design controls.
Language Proficiency: Business fluent in German (C1) and at least intermediate proficiency in English (B2).
Regulatory Knowledge: A strong understanding of Quality and Regulatory requirements for reviewing Design History File (DHF) content (such as ISO 13485 FDA GMP or experience in other heavily regulated industries).
Professional Skills: Exceptional technical writing data interpretation communication collaboration and facilitation skills along with the ability to focus on the right degree of detail.
AI & Tech Savviness: A solid understanding of or curiosity about AI capabilities and models enabling you to support our tech-driven compliance initiatives.
Mobility: Willingness to travel internationally depending upon business needs and activities.
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About Company
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.
