Design Control Quality Engineer

Designation: Design Control Quality Engineer


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.

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