Product design representative for EU-MDR regulatory approvals, design changes, and implementation.
Key Responsibilities
1.Facilitates Design Change process to gather input from all impacted functions, provide technical justification for changes, and implementation.
2. Coordinates documentations and ERP system activities to implement changes and maintain quality system compliance.
3. Modifies design history file deliverables to incorporate design changes.
4. Provides technical input to other functions such as labelign, packaging, microbiology, regulatory, and manufacturing.
5. Manages function specific tasks and reports status to project management.
6. Liases with peers who have product-specific knowledge to ensure defendable documentation.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD
Medical Device experience
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.