Senior Quality Engineer - Medical Devices (Onsite)

Intellectt INC; North Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc. is seeking a Senior Quality Engineer for an onsite role in North Haven, CT. The candidate will support manufacturing and product quality improvements, lead investigations, and perform root-cause analyses with CAPA and NCR processes.

The role requires experience with process validation, IQ/OQ/PQ, and equipment qualification, plus strong knowledge of regulatory standards such as FDA 21 CFR Part 820 and ISO 13485. Collaboration across cross-functional teams is essential.

Qualifications

• Bachelor's degree in Engineering or related field.
• 4+ years of Quality Engineering experience in a regulated manufacturing environment.
• Experience with CAPA, NCR, Root Cause Analysis, Process Validation, Change Control, and Risk Management.
• Strong knowledge of statistical analysis and quality improvement tools.

Responsibilities

• Support manufacturing quality and product quality improvements.
• Lead investigations for NCRs, CAPAs, deviations, and customer complaints.
• Perform root cause analysis using tools such as 5 Why, Fishbone, and PFMEA.
• Support IQ/OQ/PQ, process validation, and equipment qualification.
• Review and approve validation protocols, engineering changes, and quality documentation.
• Conduct risk assessments and participate in DFMEA/PFMEA activities.
• Collaborate with Manufacturing, R&D, Regulatory, and Supplier Quality teams.
• Ensure compliance with FDA, ISO 13485, and quality management system requirements.

Skills

CAPA

NCR

Root Cause Analysis

Process Validation

Change Control

Risk Management

Statistical Analysis

Quality Improvement Tools

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

DOE

Job description

Intellectt Inc. is seeking a Senior Quality Engineer for an onsite role in North Haven, CT. The candidate will support manufacturing and product quality improvements, lead investigations, and perform root-cause analyses with CAPA and NCR processes.

The role requires experience with process validation, IQ/OQ/PQ, and equipment qualification, plus strong knowledge of regulatory standards such as FDA 21 CFR Part 820 and ISO 13485. Collaboration across cross-functional teams is essential.