Design Quality Engineer

Shoolin Inc; New Jersey; On-site; USD 85,000 - 105,000; Full time

Job summary

Shoolin Inc is seeking a Design Quality Engineer with medical device experience to support product development, design controls, risk management, and quality activities throughout the lifecycle. You will review and approve design and quality documentation to regulatory requirements and collaborate with R&D, Engineering, Manufacturing, and Regulatory teams to resolve quality issues.

This role requires 3–4 years in design quality within medical devices and a degree in Engineering, Quality,

Qualifications

• 3–4 years of Design Quality / Quality Engineering experience in the medical device industry.
• Strong experience with Design Controls, DHF, DMR, and Design History documentation.
• Hands-on knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Experience with Risk Management, FMEA, and risk assessments.
• Experience supporting NPI, Design Transfer, Verification & Validation.
• Knowledge of CAPA, NCR/Nonconformance, deviations, and change control.
• Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or related field.

Responsibilities

• Support Design Quality activities throughout the product development and NPI lifecycle.
• Review and approve design and quality documentation in compliance with regulatory requirements.
• Support design reviews, risk management, FMEA, V&V, and design transfer.
• Partner with R&D, Engineering, Manufacturing, and Regulatory teams to resolve quality issues.
• Support CAPA, NCRs, investigations, and change control.
• Ensure products and processes meet applicable medical device quality and regulatory standards.

Skills

Design Quality

Medical Devices

Design Controls

Risk Management

NPI & Transfer

FMEA

CAPA

Education

Bachelor’s in Engineering/Quality/Bio Eng

Job description

Seeking a Design Quality Engineer with strong medical device experience to support product development, design controls, risk management, and quality activities throughout the product lifecycle.

Required Experience:

• 3–4 years of Design Quality / Quality Engineering experience in the medical device industry
• Strong experience with Design Controls, DHF, DMR, and Design History documentation
• Hands-on knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
• Experience with Risk Management, FMEA, and risk assessments
• Experience supporting NPI, Design Transfer, Verification & Validation
• Knowledge of CAPA, NCR/Nonconformance, deviations, and change control
• Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or related field

Key Responsibilities:

• Support Design Quality activities throughout the product development and NPI lifecycle.
• Review and approve design and quality documentation in compliance with regulatory requirements.
• Support design reviews, risk management, FMEA, V&V, and design transfer activities.
• Partner with R&D, Engineering, Manufacturing, and Regulatory teams to resolve quality issues.
• Support CAPA, NCRs, investigations, and change control activities.
• Ensure products and processes meet applicable medical device quality and regulatory standards.