Description

Minimum degree requirement in Mechanical Engineering or a closely related field.

• Update the Redlines for Design Control documents, provide feedback and recommendation for identified issues.
• Review and assess the complete DHF for various product line and device history file documents for planning.
• Review primary missing documents for Design Input and Design Output, Design Product requirements, Design Customer requirements and Applicable standards/ Essential requirements.
• Verify Design History File (DHF) deliverables, review the deliverables and perform GAP analysis.
• Provide input for changes in the Design Customer requirements.
• Update the Design Customer requirements procedures to ensure compliance with 21 CFR820, ISO 10993, International and FDA regulatory and safety standards.
• Evaluate and implement changes for the Design Input/Design Output documents.
• Create Work Instructions, update SOPs and ensure compliance with the governing rules and regulations
• Enhanced ability to implement projects and compliance programs, understand policies and procedures and governing compliance requirements for medical devices.

• Updated the Design Control procedures to ensure compliance with 21 CFR 820.

• Participated in product development team meetings, representing Quality.
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.
• Tracked and maintained compliance records and documents
• Reviewed documents, including Risk Analysis, FMEA, Technical Reports, product labeling and marketing literature.
• Performed assessments on previously validated Design Verification and Validation documents.
• Set up design and development process as per 21 CFR 820.30, ISO13485 and ISO 10993 requirements
• Work with the SMEs and internal and external Reviewers to identify gaps and mitigate the risks
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.