DQE with Component Qualification

Excelon Solutions; Raritan (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Excelon Solutions in New Jersey seeks a Design Quality Engineer (DQE) specializing in Component Qualification for medical devices. You will contribute hands-on across DHF, IQ/OQ/PQ, TMV, and supplier changes to maintain compliance with ISO 13485 and FDA 820.

You will lead risk management activities, review design deliverables, and participate in design reviews to ensure product meets regulatory and customer requirements.

Qualifications

• Hands-on experience in medical device design and development.
• Experience with FDA-regulated Design Controls, Change Controls and NPD.
• Experience in Component Qualification and Process Validation.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Assess product, process, and supplier changes for quality/regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.

Responsibilities

• Review and approve DHF deliverables and quality documentation.
• Participate in CAPA and nonconformance investigations.
• Lead risk management activities, including hazard analysis and FMEAs.
• Review verification, validation, and design transfer deliverables.
• Perform audits, inspections, and serve as Design Quality SME.
• Assess changes to product, process, and suppliers for regulatory impact.
• Support design reviews to ensure regulatory and product requirements.

Skills

Medical device design

FDA Design Controls

Change Control

NPD

Component Qualification

Process Validation

ISO 13485

FDA 21 CFR Part 820

Risk Management (FMEAs)

Document Review

Tools

IQ

OQ

PQ

TMV

Gage R&R

Job description

Title: DQE with Component Qualification

Location: Raritan, NJ

Keywords: Medical Device - Design Control ,ISO 13485, ISO 14971 and FDA 21 CFR Part 820

Design History Files (DHF),Component Qualification, Product Risk Management, IQ, OQ, PQ, TMV, MSA

• Hands-on experience in medical device design and development.
• Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
• Hands-on experience in Component Qualification and Process Validation activities.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product, process, and supplier changes for quality and regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.