Job Description
Job Description:
- We are looking a Senior Design Quality Engineer to support quality assurance activities for electromechanical medical devices and combination products, including infusion systems and drug-device delivery platforms. This role works closely with R&D, Manufacturing, and Regulatory teams to ensure products are developed and manufactured in compliance with medical device quality and regulatory requirements.
- This is a hands-on quality engineering role focused on design controls, verification & validation, risk management, and product lifecycle quality support.
Roles & Responsibilities:
- Support quality activities across the product lifecycle for electromechanical and combination medical devices.
- Apply Design Controls (21 CFR 820.30 / ISO 13485) during product development.
- Review and appr...