Posted:
11/13/2024, 3:03:34 AM
Location(s):
Tamaulipas, Mexico ⋅ Reynosa, Tamaulipas, Mexico
Experience Level(s):
Mid Level
Field(s):
IT & Security
About the role
Facilitate that the design control process and Change control process are followed properly by writing and reviewing the documentation applicable.
Key Responsabilities:
• Responsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks.
• Responsible for creating and finalizing DDP, DI-TM, Technical design review plan & report.
• Responsible for recording and documenting the needed actions from TDRs, coordinate the actions and ensure action overview is prepared, reviewed and approved and any changes are controlled.
• Chair and facilitate technical design reviews (agenda and minutes).
• Conduct teaching and coaching during introduction or updates on procedures and instructions related to R&D design control.
Requirements:
• Bachelor’s degree in Industrial Engineering, Process Engineering or related careers.
• Approximately 3 years of experience in product development.
• Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations.
• English proficiency: Intermediate - Advanced.
• Desirable experience in Medical Device
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Website: https://convatec.com/
Headquarter Location: Reading, Reading, United Kingdom
Employee Count: 5001-10000
Year Founded: 1978
IPO Status: Private
Industries: Commercial ⋅ Health Care ⋅ Medical Device