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Location: Gurugram
Job ID: SS202500040
Function: Design Quality
Role: Design Quality
Desired Skills: DHF, Design Verification, Design Control
Responsibilities:
- Be a part of the sustaining project team, working in design quality engineering throughout the product lifecycle.
- Ensure creation and proper execution of Project/Sustaining Quality Deliverables (e.g., Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, Software Validation Plan if applicable).
- Work on product DHF, design input/output, risk management, usability, verification, and validation efforts for commercial products.
- Manage electronic document control and version control for all project-related documents.
- Ensure adherence to quality systems, design assurance SOPs, and Boston Scientific’s PLCP.
- Provide guidance on quality and regulatory compliance to product development or design change teams to ensure compliance with laws and regulations of target markets.
- Lead implementation of assurances, process controls, and CAPA systems to meet or exceed requirements.
Additional Details
- Seniority level: Entry level
- Employment type: Full-time
- Job function: Quality Assurance
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