Design Quality Engineer

United Pharma; New Jersey; On-site; USD 110,000 - 135,000; Full time

Job summary

United Pharma in New Jersey is seeking an experienced Design Quality Engineer to join our Medical Device team. The role requires strong knowledge of design controls, product development, quality systems, and regulatory compliance to support development and commercialization of medical devices.

The successful candidate will ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971, lead Design Control activities, and collaborate with R&D, Manufacturing, Regulatory Affairs, and

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Design Quality Engineering experience in Medical Devices.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, Design Controls, and ISO 14971.
• Experience with Design Verification and Validation activities.
• ASQ CQE certification is a plus.

Responsibilities

• Support product development activities from concept through commercialization.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements.
• Lead Design Control activities including Design Reviews, Design Verification, Design Validation, and Design Transfer.
• Develop and maintain DHF, DMR, and technical documentation.
• Perform risk management activities per ISO 14971 including DFMEA and risk assessments.
• Review ECOs and assess product quality impact.
• Support CAPA, nonconformance investigations, and root cause analysis.
• Partner with R&D, Manufacturing, Regulatory Affairs, and Operations to ensure product quality.
• Participate in internal and external quality audits.

Skills

Design Quality Engineering

Quality Systems

Regulatory Compliance

Communication

Documentation

Problem-solving

Education

Bachelor's degree in Engineering

Job description

Hiring: Design Quality Engineer – Medical Devices

We are looking for an experienced Design Quality Engineer to join our Medical Device team. The ideal candidate will have a strong understanding of design controls, product development, quality systems, and regulatory compliance while supporting the development and commercialization of innovative medical devices.

Location: NJ, Onsite, USA

Responsibilities:

• Support product development activities from concept through commercialization.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements.
• Lead Design Control activities including Design Reviews, Design Verification, Design Validation, and Design Transfer.
• Develop and maintain Design History Files (DHF), Device Master Records (DMR), and technical documentation.
• Perform risk management activities in accordance with ISO 14971, including DFMEA and risk assessments.
• Review Engineering Change Orders (ECOs) and assess product quality impact.
• Support CAPA, nonconformance investigations, and root cause analysis.
• Partner with R&D, Manufacturing, Regulatory Affairs, and Operations to ensure product quality throughout the product lifecycle.
• Participate in internal and external quality audits.

Required Qualifications:

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of Design Quality Engineering experience within the Medical Device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, Design Controls, and ISO 14971.
• Experience with Design Verification and Validation activities.
• Excellent communication, documentation, and problem-solving skills.
• ASQ Certified Quality Engineer (CQE) certification is a plus.

Preferred Experience:

• Experience with Class II or Class III Medical Devices.
• Knowledge of product development and New Product Introduction (NPI).
• Familiarity with CAPA, NCR, FMEA, and Root Cause Analysis.