Senior Design Quality & Compliance Engineer

Philips; Tennessee; On-site; USD 102,000 - 164,000; Full time

Job summary

The Senior Design Quality Engineer at Philips leads the full design control process for medical devices, validating inputs, overseeing verification and validation, and managing design transfer to production. You will drive process validation strategies, apply statistical tools, and ensure compliance with FDA/regulatory standards throughout the product lifecycle.

You will develop quality plans for hardware, software, and systems, perform risk assessment using ISO 14971, manage CAPA, and guide

Qualifications

• Minimum of a Bachelor’s Degree in Quality, Engineering or similar disciplines.
• ASQ-CQE and ISO Lead Auditor certification are desired.
• Experience in FDA-regulated medical devices and Design Assurance/Control.
• Knowledge of ISO 14971 risk management and QMS for design controls.
• Experience in CAPA processes and data analytics.

Responsibilities

• Lead the full design control process from inputs to verification and transfer.
• Develop and execute comprehensive process validation strategies.
• Apply statistics to ensure production readiness and regulatory compliance.
• Drive CAPA, root-cause analysis and continuous improvement activities.

Skills

Design Assurance/Control

Risk Management (ISO 14971)

QMS Design Controls

CAPA processes

Root cause analysis

Education

Bachelor’s Degree in Quality, Engineering or similar

Job description

The Senior Design Quality Engineer at Philips leads the full design control process for medical devices, validating inputs, overseeing verification and validation, and managing design transfer to production. You will drive process validation strategies, apply statistical tools, and ensure compliance with FDA/regulatory standards throughout the product lifecycle.

You will develop quality plans for hardware, software, and systems, perform risk assessment using ISO 14971, manage CAPA, and guide