Quality CAPA Investigator & Root Cause Lead

Validation & Engineering Group; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group in the United States is seeking a QA CAPA Investigation Specialist to conduct and document quality investigations, CAPAs, deviations, and related quality events within a regulated manufacturing environment.

You will perform root cause analysis using structured methods, gather data, prepare investigation reports, support corrective actions, track progress, and collaborate with cross-functional teams to ensure timely, evidence-based resolutions.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, or related technical discipline.
• Typically 3–5 years of experience in QA, Quality Compliance, Investigations, CAPA or related FDA-regulated function.
• Hands-on experience conducting or supporting CAPAs, deviations, nonconformances or quality investigations.
• Working knowledge of structured root cause analysis and problem-solving methodologies.
• Strong technical writing and documentation skills.
• Strong analytical and organizational skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Conduct and document quality investigations, CAPAs, nonconformances and related quality events.
• Gather and analyze relevant data records and supporting documentation.
• Perform structured root cause analysis using methods such as 5 Whys and Fishbone/ Ishikawa.
• Identify root causes, contributing factors, and potential systemic issues.
• Prepare clear, accurate, and technically sound investigation reports.
• Support development and implementation of corrective and preventive actions.
• Track assigned CAPA and investigation activities through completion.
• Support effectiveness checks to verify actions achieve intended results.
• Collaborate with cross-functional stakeholders to obtain information and resolve open items within timelines.
• Review supporting documentation to ensure conclusions are evidence-based.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness as needed.
• Maintain complete and timely documentation in accordance with procedures and regulatory requirements.

Skills

CAPA investigations

Root cause analysis

Data analysis

Technical writing

Cross-functional collaboration

Communication

multitasking

Education

Bachelor's degree in Engineering/Science/Quality/Manufacturing

Tools

FMEA

Electronic Quality Management Systems

Job description

Validation & Engineering Group in the United States is seeking a QA CAPA Investigation Specialist to conduct and document quality investigations, CAPAs, deviations, and related quality events within a regulated manufacturing environment.

You will perform root cause analysis using structured methods, gather data, prepare investigation reports, support corrective actions, track progress, and collaborate with cross-functional teams to ensure timely, evidence-based resolutions.