Senior Quality Engineer - Med Device, FDA-Regulated

JobDiva, Inc.; Brooklyn Park (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

JobDiva, Inc. urgently seeks a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. You will lead quality engineering efforts, manage transfers and validation activities, and ensure compliance with PFMEA, CAPA, and ISO 13485 requirements.

Ideal candidates have extensive experience with IQ/OQ/PQ validation, FDA 21 CFR Part 820, and robust technical writing skills to maintain compliant documentation and support audits.

Qualifications

• 10+ years of Quality Engineering experience in medical device manufacturing.
• Strong experience with FDA-regulated environments & Quality Systems.
• Hands-on Technology/Product/Process/Manufacturing Transfers.
• Validation experience: IQ/OQ/PQ, TMV & Process Validation.
• FDA-compliant quality documentation.
• PFMEA, Control Plans, Nonconformance & CAPA.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.
• Customer complaint investigations & Root Cause Analysis.
• Manufacturing readiness, NPI & scale-up.
• Strong technical writing and documentation skills.
• Internal/external audit support preferred.
• Injection molding, assembly or contract manufacturing experience is a plus

Responsibilities

• Lead quality engineering efforts in FDA-regulated medical device manufacturing.
• Oversee product/process transfers and validation activities.
• Develop and maintain PFMEA, Control Plans and CAPA systems.
• Prepare FDA 21 CFR Part 820 compliant documentation.
• Support internal and external audits.
• Drive manufacturing readiness, NPI and scale-up.
• Maintain ISO 13485 and risk management processes.

Skills

Quality Engineering

FDA-regulated environments

Root Cause Analysis

Documentation

Technical Writing

CAPA

PFMEA

Process Validation

Tools

IQ/OQ/PQ Validation

Quality Systems

ISO 13485

FDA 21 CFR Part 820

Job description

JobDiva, Inc. urgently seeks a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. You will lead quality engineering efforts, manage transfers and validation activities, and ensure compliance with PFMEA, CAPA, and ISO 13485 requirements.

Ideal candidates have extensive experience with IQ/OQ/PQ validation, FDA 21 CFR Part 820, and robust technical writing skills to maintain compliant documentation and support audits.