Quality Test Engineer – Hands-On Medical Device Lab

SRG; Irvine (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Impellam Group's client, a medical device manufacturer, is seeking a Quality Test Engineer to support root-cause investigations for customer complaints and drive CAPA actions in a hands-on lab setting. This role involves electrical testing, data analysis, risk assessment, and collaboration with cross-functional teams to ensure compliance with ISO 13485 and FDA QSR.

Ideal for an early-career engineer with 2+ years of experience in medical device testing and a strong grounding in statistics and

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.

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.

Skills

Electrical testing

Root-cause analysis

CAPA

Risk assessment

Excel

Data analysis

Written communication

Problem solving

Education

Bachelor's degree in Engineering

Tools

Minitab

QI Macros

NCR tracking software

FMEA tools

Job description

Impellam Group's client, a medical device manufacturer, is seeking a Quality Test Engineer to support root-cause investigations for customer complaints and drive CAPA actions in a hands-on lab setting. This role involves electrical testing, data analysis, risk assessment, and collaboration with cross-functional teams to ensure compliance with ISO 13485 and FDA QSR.

Ideal for an early-career engineer with 2+ years of experience in medical device testing and a strong grounding in statistics and