Job Description
The Design Quality Engineer will act as the quality representative and design control lead on cross-functional new product development (NPD) and sustaining engineering teams. This role ensures that orthopedic implants and associated instrumentation are developed and manufactured in compliance with internal QMS, FDA 21 CFR 820, ISO 13485, and ISO 14971 standards. The ideal candidate will facilitate risk management activities, verify design outputs, and ensure a smooth design transfer to manufacturing.
Responsibilities
- Design Control Leadership: Lead and support Design Control activities (planning, design inputs, outputs, verification, validation, and design transfer) across the product lifecycle.
- Risk Management: Facilitate and lead risk management activities, including development of Risk Management Plans, Hazard Analysis, and Design Failure Mode Effects Analysis (DFMEA) for orthopedic products.
- Verification & Validat...