Principal QA Engineer - Medical Devices & Design Control

Philips International; Gainesville (FL); On-site; USD 120,000 - 170,000; Full time

Job summary

Philips, a health technology company, is seeking a Principal Quality Assurance Engineer in Gainesville, FL to plan and execute comprehensive process validation strategies using statistical tools to ensure smooth transition of new products to production while meeting quality and regulatory standards.

The role leads the design control process across the product lifecycle, drives CAPA and PMS activities, and guides risk management to maintain product safety and quality, with onsite work and

Qualifications

• Bachelor's or Master's degree in engineering or science.
• 5+ years of experience in medical device quality, design QA, risk management, or equivalent.
• 8+ years of experience with medical device regulations and Design Quality Management.

Responsibilities

• Plans and executes comprehensive process validation strategies using statistical tools.
• Leads the design control process from inputs to design transfer, ensuring regulatory compliance.
• Leads quality improvement projects and CAPA processes across the product lifecycle.
• Validates critical design inputs: usability, reliability, manufacturability, and safety.
• Guides risk management activities to identify, assess, and mitigate risks.

Skills

Quality assurance

CAPA

Root cause analysis

Data analysis

Risk management

Design control

Regulatory standards

Education

Bachelor's or Master's degree in engineering/science

Tools

Statistical tools

Job description

Philips, a health technology company, is seeking a Principal Quality Assurance Engineer in Gainesville, FL to plan and execute comprehensive process validation strategies using statistical tools to ensure smooth transition of new products to production while meeting quality and regulatory standards.

The role leads the design control process across the product lifecycle, drives CAPA and PMS activities, and guides risk management to maintain product safety and quality, with onsite work and