Quality Engineer

About the Role

Our client, a medical device manufacturer, is seeking a Quality Test Engineer to support root-cause investigations for customer complaints and drive corrective and preventive actions. This is a hands-on lab-based role (gloves/PPE, not a full cleanroom) with direct exposure to electrical testing, complaint investigations, and cross-functional quality improvement projects. This is an excellent opportunity for an early-career quality/test engineer to build depth in complaint investigation, risk assessment, and regulated medical device testing.

• Hands-on lab environment working directly with medical device testing (not a desk-only QA role)
• Broad device exposure - great for building a diversified quality engineering background
• Direct mentorship and reporting line to the hiring manager
• Strong foundation-building role for someone early in their quality/test engineering career

Responsibilities

• Investigate customer complaints related to product design, manufacturing, and testing
• Document non-conformances (NCs) and support formal investigations
• Perform electrical testing on medical devices as part of complaint resolution
• Participate in CAPA trending meetings and contribute to root-cause and corrective action efforts
• Apply risk assessment principles to evaluate product and process issues
• Analyze data using engineering principles to support continuous improvement initiatives
• Support internal and external quality audits
• Communicate quality trends and business-impacting issues to management
• Comply with all applicable federal, state, local, and company health, safety, and environmental regulations

Qualifications

• Bachelor's degree in Engineering
• 2+ years of experience in an engineering-related field (Level 1 role)
• Experience with medical device testing required
• Ability to read and interpret electrical and mechanical schematics
• Experience with electrical testing methods
• Strong understanding of risk assessment principles
• Proficiency in Excel strongly preferred
• Experience with multiple device types; ENT device experience a plus (any medical device background considered)
• Familiarity with statistics and data analysis
• Strong root-cause and problem-solving skills
• Effective verbal and written communication skills
• Knowledge of Six Sigma / Process Excellence tools a plus
• Familiarity with FMEA and Fault Tree Analysis a plus
• Understanding of Human Factors and Health Hazard Risk analysis a plus
• Knowledge of ISO 13485, FDA Quality System Regulation, and ISO 14971 a plus
• Experience with Minitab, QI Macros, or similar quality software a plus
• Experience with CAPA, NCR, or audit tracking software a plus