Technical/Designer intern assisting engineering tasks like measurements and drafting at We Energies. Requires students with valid licenses and availability during summer.
About the role
- 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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