Design Quality Partner ensuring project milestone readiness and quality management for healthcare solutions at Roche. Collaborating cross-functionally for efficient product development and regulatory compliance.
Responsibilities
Ensure effective partnerships within Q&R and related functions
Enable project acceleration by efficient and timely milestone achievement
Enable an efficient document review process focusing on design control deliverables
Partner with the Strategic Quality Partner and stakeholders to ensure milestone readiness and achievement
Review and approve milestone deliverables within development projects
Represent Pre Market Quality in mQMS Communities of Practice
Support internal and external audits
Drive standardization of deliverables across projects and Customer areas
Ensure timely execution and quality process management for design change requests, NCs and CAPA
Model behavior to support and enable new ways of working and a culture of continuous improvement
Adopt Risk Enabler in decision making
Reduce complexity and drive continuous improvement across customer areas
Requirements
Bachelor's degree in Mechanical or Chemical Engineering or a related field
3+ years of related experience
Strong design control/Quality Management System 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
Background in matrix-leadership for a global project team
Preferred Mandarin language proficiency is considered an advantage
Experience supporting the design and development of Hardware and Software systems and assay development is considered an advantage.
Experience working in a global setting is considered an advantage
MBA or advanced degree is considered an advantage
Benefits
A discretionary annual bonus may be available based on individual and Company performance
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