Design Quality Engineer
Location
Bedford, MA
Level
Senior-Level
Department
MedTech
Type
Salary
$102,000 - $164,000
Job Description
Posted on:
2026-03-30
Responsibilities
- Plan and execute process validation strategies using statistical tools.
- Manage the design control process, including validation and design transfer.
- Draft and maintain quality engineering documents to ensure compliance.
- Conduct assessments and root cause analyses to address quality deficiencies.
- Validate design inputs such as usability, reliability, and safety.
- Guide risk management activities throughout the product lifecycle.
- Prepare for quality audits and maintain necessary documentation.
Job Requirements
- Minimum 5+ years in FDA regulated medical device environments.
- Experience in Design Verification/Validation and Root Cause analysis.
- Knowledge of Risk Management (ISO 14971).
- Experience in CAPA processes and continuous improvement.
- Bachelor's Degree in Quality, Engineering, or similar disciplines.
- ASQ-CQE, ISO 13485 training, and ISO Lead Auditor certification desired.
- Ability to perform physical, cognitive, and environmental job requirements.
