Contract position: A Design Quality Engineer is needed for a leader in developing and providing healthcare in the Lexington, MA area. This role will provide technical quality leadership and support for the company's medical device and combination product development efforts throughout clinical development, product registration, and commercialization. No per diem is available.Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- This DQE will support class 2 electromechanical and reconstitution devices, and other drug delivery devices as required.
- This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes.
- This DQE team member will ensure the company develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).
- Experience in a similar role.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.