Senior Quality Leader, Advanced Imaging Systems

Philips; Bedford (MA); On-site; USD 134,000 - 213,000; Full time

Benefits offered by this job

PTO

401(k) match

HSA contribution

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Quality Manager-Advanced Imaging to lead the QMS and Design Assurance for life‑saving Image Guided Therapy products across their lifecycle.

The role drives quality strategy, regulatory readiness, and continuous improvement through data‑driven decisions, while building a strong quality organization and cross‑functional partnerships with R&D, Operations, and Regulatory affairs.

Qualifications

• Minimum 8+ years in FDA regulated medical device environments with focus on QMS Compliance and Design Assurance.
• Proven experience managing quality teams including budgeting, workforce planning and coaching.
• Strong knowledge of ISO 13485/14971, 21 CFR (803, 806, 820), MDD/EU MDR, GMP, GDP.
• Extensive experience leading audit readiness and regulatory inspections.

Responsibilities

• Lead Quality functions as a strategic member of the leadership team, fostering a culture of quality and continuous improvement.
• Oversee QMS compliance with global regulations and standards, including FDA QMSR, ISO 13485, MDR.
• Serve as primary quality representative for regulatory inspections and audits with authorities and notified bodies.
• Establish and improve quality processes to deliver safe, effective products throughout the lifecycle.

Skills

QMS Compliance

Design Assurance

Regulatory Audits

Root Cause Analysis

CAPA

Data Analysis

Team Leadership

Risk Management

Cross-functional Leadership

Education

Bachelor’s Degree in Quality/Engineering

Job description

Philips in Bedford, MA seeks a Senior Quality Manager-Advanced Imaging to lead the QMS and Design Assurance for life‑saving Image Guided Therapy products across their lifecycle.

The role drives quality strategy, regulatory readiness, and continuous improvement through data‑driven decisions, while building a strong quality organization and cross‑functional partnerships with R&D, Operations, and Regulatory affairs.