Senior QA Engineer - Medical Devices | CAPA & NC

Ledgent Technology; Redmond; On-site; AUD 128,000 - 140,000; Full time

Job summary

Ledgent Technology seeks a Sr. QA Engineer to join a client site in Redmond, WA. You will own CAPA/NC records, coordinate with Operations and suppliers, and drive quality improvements across manufacturing processes.

Responsibilities include root-cause analysis, problem-solving, and validation activities, with exposure to medical device quality systems and TrackWise/MASTERCONTROL usage. Location is on-site with some flexibility after training.

Qualifications

• Engineering or science degree (BS).
• Experience with CAPA/NC management in a regulated environment.
• Knowledge of TrackWise, MasterControl, and SAP preferred.
• Strong root cause analysis and problem-solving skills.
• Ability to collaborate with cross-functional teams.

Responsibilities

• Investigate non-conformances, CAPAs, and quality issues.
• Perform root cause analysis and lead problem-solving huddles.
• Collaborate with Operations and suppliers to address quality issues.
• Support manufacturing transfers and supplier quality activities.
• Maintain KPIs and monitor trends to drive improvements.

Skills

CAPA management

NC tracking

Root cause analysis

Quality systems

Cross-functional collaboration

Education

BS engineering

Tools

TrackWise

MasterControl

SAP

Job description

Ledgent Technology seeks a Sr. QA Engineer to join a client site in Redmond, WA. You will own CAPA/NC records, coordinate with Operations and suppliers, and drive quality improvements across manufacturing processes.

Responsibilities include root-cause analysis, problem-solving, and validation activities, with exposure to medical device quality systems and TrackWise/MASTERCONTROL usage. Location is on-site with some flexibility after training.