Design Quality Expert
hace 1 mes
Design Quality Partner Role
We are seeking a highly motivated Design Quality Partner to join our Product Development Quality organization. As a 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.
Key Responsibilities
- 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.
- Ensure timely execution and quality process management for design change requests, NCs and CAPA.
Requirements
- Bachelor's degree in engineering, business administration or a related field.
- 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.
- Knowledge of Regulations pertaining to the environment.
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.
Operating Principles
The Design Quality Partner is expected to demonstrate the Roche Operating Principles and contribute to the Roche Group.
About Roche
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups.
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