Senior Design Quality Engineer, Medical Devices (QMS)

Regulatory Jobs; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA is seeking a Senior Design Quality Engineer to lead the design control process for medical devices, overseeing inputs, verification, validation, and design transfer. You will drive process validation, CAPA, risk management, and PMS analytics to ensure regulatory and quality standards are met throughout the product lifecycle.

The role requires 5+ years in FDA-regulated environments, strong knowledge of ISO 14971, and a Bachelor’s in quality/engineering.

Qualifications

• 5+ years in FDA-regulated medical device environments focusing on design assurance and control.
• Deep knowledge of ISO 14971 risk management and QMS related to design controls.
• Experience with design verification/validation, CAPA and traceability.

Responsibilities

• Lead design control from inputs to verification, validation, and design transfer.
• Plan and execute process validation strategies using statistical tools.
• Draft and maintain quality plans for hardware, software, and systems.
• Perform risk management throughout the product lifecycle and lead PMS insights.
• Prepare for quality audits and inspections with comprehensive documentation.
• Manage CAPA processes and root cause analysis to prevent recurrence.

Skills

Regulatory experience

Design Assurance/Control

Risk Management ISO14971

QMS knowledge

CAPA processes

Data analytics

Post Market Surveillance

Education

Bachelor’s Degree in quality or engineering

ASQ-CQE or ISO Lead Auditor (desirable)

Tools

Audit tools

Quality documentation tools

Job description

Philips in Bedford, MA is seeking a Senior Design Quality Engineer to lead the design control process for medical devices, overseeing inputs, verification, validation, and design transfer. You will drive process validation, CAPA, risk management, and PMS analytics to ensure regulatory and quality standards are met throughout the product lifecycle.

The role requires 5+ years in FDA-regulated environments, strong knowledge of ISO 14971, and a Bachelor’s in quality/engineering.