Quality Engineer - CAPA & RCA (Medical Devices)

L&T Technology Services; Draper (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

L&T Technology Services in Utah is seeking a Quality Engineer to own CAPA records end-to-end, investigate root causes, implement corrective actions, and verify effectiveness in a regulated medical device environment.

You will lead RCA using 5 Whys, Fishbone, Fault Tree, 8D, and DMAIC, ensure documentation meets ISO 13485 and FDA 21 CFR 820, and collaborate with Manufacturing, Operations, R&D, and Supplier Quality to drive audit readiness.

Qualifications

• 5–7+ years of Quality Engineering experience.
• Strong CAPA, NCR/NCMR, RCA, and technical documentation experience.
• Medical device or regulated manufacturing experience.
• Experience with ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Own CAPA records end-to-end, including investigation, root cause, corrective actions, effectiveness checks, and closure.
• Lead RCA using 5 Whys, Fishbone, Fault Tree Analysis, 8D, and DMAIC.
• Ensure CAPA and Quality System documentation meets ISO 13485 and FDA 21 CFR 820 requirements.
• Partner with Manufacturing, Operations, R&D, and Supplier Quality teams to implement corrective actions.
• Perform data trending/statistical analysis to verify CAPA effectiveness and support audit readiness.
• Maintain accurate records in eQMS systems such as TrackWise, MasterControl, or equivalent.

Skills

CAPA management

NCR/NCMR

Root Cause Analysis

5 Whys / Fishbone / FTA / 8D / DMAIC

Data analysis

Education

Bachelor's degree in Engineering

Tools

TrackWise

MasterControl

Job description

L&T Technology Services in Utah is seeking a Quality Engineer to own CAPA records end-to-end, investigate root causes, implement corrective actions, and verify effectiveness in a regulated medical device environment.

You will lead RCA using 5 Whys, Fishbone, Fault Tree, 8D, and DMAIC, ensure documentation meets ISO 13485 and FDA 21 CFR 820, and collaborate with Manufacturing, Operations, R&D, and Supplier Quality to drive audit readiness.