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Associate Failure Analysis Engineer
Job in
Acton, Middlesex County, Massachusetts, 01720, USA
Listed on 2026-10-27
Listing for:
Employee Workplace
Full Time
position Listed on 2026-10-27
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Production QC/QA -
Engineering
Quality Engineering
Job Description & How to Apply Below
Acton, MA | $50/hour
Are you an engineer or quality professional with experience in product testing, root cause analysis, and quality investigations? We are seeking an Associate Failure Analysis Engineer to support post-market investigations and quality assurance activities for regulated medical devices. This is a hands‑on opportunity to work in a quality-focused environment, helping identify product issues, analyze failure modes, and drive continuous improvement.
What You'll Do- Conduct product testing, failure analysis, and root cause investigations
- Perform investigation triage and develop hypotheses for product failures
- Review quality records, device history records (DHRs), and lot acceptance documentation
- Analyze quality data, track trends, and create reports using Excel
- Support CAPA, NCR, training, audit, and quality system documentation
- Partner with engineering and quality teams to improve inspection and testing processes
- Troubleshoot new failure modes and recommend corrective actions
- Assist with FDA and ISO audit preparation activities
- Apply Lean Six Sigma and continuous improvement principles to enhance quality and efficiency
- Bachelor's degree in Engineering, Science, or a related field, or equivalent experience
- Experience in quality engineering, failure analysis, testing, or regulated manufacturing environments
- Strong Excel and data analysis skills
- Excellent technical writing, documentation, and organizational abilities
- Electrical and mechanical troubleshooting experience preferred
- Knowledge of ISO 13485, QSR, Lean Manufacturing, Six Sigma, SPC, or ASQ principles is a plus
- Medical, dental, vision, and pet insurance
- 401(k) Retirement Savings Plan
- Employee Assistance Program (EAP)
- Commuter/Parking Accounts
- People Perks Program
- Health Savings Account (HSA)
- Accidental Death & Dismemberment (AD&D) Insurance
Position Requirements
10+ Years
work experience
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