Loading, Please wait..!!
Design Quality Engineer Dqe
-
Posted on: Oct 13, 2026
-
Westchester, Massachusetts
-
Onsite
-
Full-time
Curious about compensation?
Explore the historical salary trends, average pay, and estimated compensation for Design Quality Engineer Dqe roles in Massachusetts.
View Salary Guide →Find your match !
Job Title :
Design Quality Engineer Dqe
Job Type :
Full-Time
Job Location :
Westchester Massachusetts United States
Remote :
No
Job Description :
- 8+ years of Design Quality / Medical Device Engineering experience
- Experience in Medical Device / MedTech manufacturing
- Strong knowledge of Design Controls
- Experience with Risk Management ISO 14971
- Design Verification & Validation (DV/V)
- Design Reviews and design quality activities
- CAPA, NCR, deviations and complaint investigations
- Root Cause Analysis & problem solving
- Change Control / ECO / ECN
- FMEA / DFMEA
- Knowledge of FDA 21 CFR 820 / QMSR, ISO 13485
- Experience preparing and reviewing quality/technical documentation
- Ability to work with R&D, Manufacturing, Regulatory, Quality and Operations teams
Preferred:
- Experience with Class II / Class III medical devices
- NPI / product transfer to manufacturing
- Process validation / equipment validation
- Supplier Quality / Supplier Development
- Statistical tools / DOE / SPC
- Experience with FDA / EU MDR requirements
Ideal Candidate:
A hands-on DQE with strong medical-device design quality experience who can work closely with R&D and Manufacturing teams and drive compliance, risk management and product quality.
Position Details
Posted:
Oct 13, 2026
Reference Number:
51968-6911
Employment:
Full-time
City:
Westchester
Job Origin:
CIEPAL_ORGANIC_FEED
