Project Design Quality (PDQ) Manager

Job Description

About the Role

The Project Design Quality (PDQ) Manager is responsible for ensuring robust design control and regulatory compliance throughout the product lifecycle. This role oversees the integrity and completeness of the Design History File (DHF), ensures adherence to FDA Quality System Regulation (QSR) Design Controls, and verifies that all Critical-to-Quality (CTQ) requirements are properly defined, tested, and documented.

You will play a critical role in bridging product development, regulatory compliance, and manufacturing operations to ensure high-quality, compliant product delivery.

Key Responsibilities

Design Control & Regulatory Compliance

• Ensure the Design History File (DHF) is complete, accurate, and compliant with FDA QSR Design Control requirements
• Oversee Risk Management documentation and ensure all required design records are properly compiled
• Ensure proper compilation and maintenance of the Device Master Record (DMR)
• Manage transfer of DHF documentation from contracted design partners to Amazon, ensuring completeness and compliance

Critical-to-Quality (CTQ) & Verification

• Define and verify all CTQs (Critical-to-Quality characteristics) during design
• Ensure all critical functional requirements are validated according to approved verification and validation (V&V) protocols
• Confirm that testing and verification activities meet regulatory and quality standards

Product Transfer & Sustaining Quality

• Support product transfer to manufacturing, ensuring readiness and documentation integrity
• Manage Engineering Change Orders (ECOs) post-transfer
• Partner with Contract Manufacturers (CMs) to support issue escalation and nonconformity investigations
• Drive corrective and preventive actions (CAPA) as needed

Cross-Functional Collaboration

• Collaborate closely with Engineering, Regulatory, Manufacturing, and Supply Chain teams
• Provide quality leadership during new product development (NPD)
• Ensure quality systems integration across the product lifecycle

Ideal Candidate Profile

• Experience with FDA QSR (21 CFR Part 820) and Design Controls
• Strong understanding of DHF, DMR, Risk Management (ISO 14971 preferred), and V&V processes
• Experience supporting design transfer to manufacturing
• Familiarity with ECO management and change control processes
• Strong analytical and problem-solving skills
• Ability to work cross-functionally in regulated environments
• Excellent documentation and communication skills

Why Join Amazon?

This role offers the opportunity to ensure product quality and regulatory excellence within a fast-paced, innovation-driven environment. You will have direct impact on product integrity, compliance, and customer safety.