Responsibilities :
- Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.
- Ensure proactive compliance to all applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 19471 : 2019 and ISO 13485 : 2016.
- Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.
- Lead extended Quality teams for design change projects.
- Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, and System Risk Assessment documentation.
- May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.
- Assures that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.
- Participates in Design Reviews and develop, approve, and review associated documentation.
- Responsible for Design History File (DHF) completeness and maintenance.
- Utilize problem solving techniques and take a broad perspective to identify innovative solutions.
- Interact frequently with other functional areas and operating entities which require specialized depth and / or breadth of expertise.
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