Design Quality Engineer

Responsibilities :
• Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation.

• Ensure full compliance with design control standards such as CFR and ISO .

• Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO .

• Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle.

• Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes.

• Lead or support design verification and validation planning, execution, protocol creation, and report writing.

• Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance.

• Develop, revise, and ensure adherenc...