QvalFocus Inc. · 15 hours ago
Product Quality Engineer
Massachusetts, United States
Contract
Onsite
Mid LevelQvalFocus Inc. is seeking a Product Quality Engineer to support on-market medical devices with a strong focus on post-market failure investigations. This role involves leading complaint investigations, performing root cause analysis, and conducting risk assessments for products that have failed in the field.
Staffing & Recruiting
No H1B
Hiring Manager
Prabhakar Vempati
Responsibilities
Lead post-market complaint investigations for returned medical devices
Perform root cause analysis (RCA) to determine failure mechanisms
Conduct failure analysis and risk assessments (including FMEA)
Evaluate product, design, manufacturing, and use-related issues
Collaborate with cross-functional teams (R&D, Manufacturing, Quality, Regulatory)
Prioritize investigations based on risk, patient safety, and business impact
Recommend and support corrective and preventive actions (CAPA) where applicable
Drive product and process improvement initiatives based on investigation outcomes
Document investigation findings clearly and compliantly in quality systems
Qualification
Required
Engineering background required
Mechanical Engineering, Electrical Engineering, or closely related discipline
Experience in medical device product quality or reliability engineering
Strong hands-on experience with: Complaint investigations
Strong hands-on experience with: Root cause analysis (RCA)
Strong hands-on experience with: Failure analysis
Strong hands-on experience with: Risk management / FMEA
Experience working with returned / failed products
Solid understanding of regulated medical device environments
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
Founded in 2024
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase