Quality Engineer: CAPA, Validation & Risk (Medical Device)

Insight Global; Beverly (MA); On-site; USD 110,000 - 130,000; Full time

Job summary

Insight Global is seeking a hands-on Quality Engineer to support and improve quality systems in a regulated manufacturing environment. You will own CAPAs, investigations, process controls, validations, risk management, and quality data, partnering closely with Manufacturing, Engineering, and Operations.

The ideal candidate has implemented or improved quality processes and can drive root-cause analysis and corrective actions.

Qualifications

• 3+ years Quality Engineering experience.
• Hands-on ownership of CAPAs and nonconformance investigations.
• Strong root cause analysis.
• Able to implement corrective actions with effectiveness checks.
• ISO 13485 / FDA quality system experience.
• IQ/OQ/PQ and process validation experience.
• Lean / Six Sigma principles.
• Audit experience
• NPI / design transfer experience.
• SPC / MSA / Minitab experience.
• Cleanroom experience.

Responsibilities

• Own CAPAs, investigations, process controls, validations, risk management and quality data.
• Partner with Manufacturing, Engineering and Operations to improve quality.
• Implement and monitor corrective actions with effectiveness checks.
• Analyze quality trends and ensure compliance with ISO 13485 / FDA.

Skills

CAPA ownership

Root cause analysis

Nonconformance investigations

Education

ASQ CQE

Tools

Minitab

SPC

MSA

Job description

Insight Global is seeking a hands-on Quality Engineer to support and improve quality systems in a regulated manufacturing environment. You will own CAPAs, investigations, process controls, validations, risk management, and quality data, partnering closely with Manufacturing, Engineering, and Operations.

The ideal candidate has implemented or improved quality processes and can drive root-cause analysis and corrective actions.