Quality Systems Engineer II — CAPA & Compliance

SGS Consulting; New York (NY); On-site; USD 70,000 - 110,000; Full time

Job summary

SGS Consulting in New York, NY seeks a Quality Assurance professional to conduct investigations, perform root cause analyses, and manage CAPAs within the quality system. The role requires strong documentation practices and cross-department coordination.

You will prepare monthly metrics for quality reviews and ensure compliance with FDA, ISO 9001, ISO 13485, and other regulations. A degree in science or engineering plus 3–5+ years in QA is expected.

Qualifications

• Bachelor's degree in science or engineering preferred.
• 3 to 5+ years of experience in Quality Assurance for medical device or pharmaceutical manufacturing.
• Knowledge of investigations, root cause analysis, CAPA, and quality systems.
• Strong organizational and communication skills.

Responsibilities

• Perform essential duties satisfactorily.
• Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
• Ensure investigations and root cause analysis are accurate and complete.
• Maintain an accurate log of non-conformances and CAPAs activities.
• Track, follow up, and assist in timely closure of NCs/CAPAs.
• Provide hands-on guidance and training to personnel within the Quality system.
• Ensure documentation is complete before closure.
• Assist Quality Systems team to investigate Nonconformances and CAPAs.
• Prepare monthly and quarterly metrics for Quality Review meetings.
• Understand FDA, ISO 9001, ISO 13485, MOD, CMDR and other regulatory requirements.

Skills

Investigations & CAPA

Root cause analysis

Quality systems

Technical writing

Education

Bachelor's degree in science or engineering

Tools

MS Office Suite

Statistical software

Job description

SGS Consulting in New York, NY seeks a Quality Assurance professional to conduct investigations, perform root cause analyses, and manage CAPAs within the quality system. The role requires strong documentation practices and cross-department coordination.

You will prepare monthly metrics for quality reviews and ensure compliance with FDA, ISO 9001, ISO 13485, and other regulations. A degree in science or engineering plus 3–5+ years in QA is expected.