Senior Quality Leader – Advanced Imaging (Office-Based)

Mass Digital Health; Massachusetts; On-site; USD 134,000 - 213,000; Full time

Job summary

Philips in Bedford, MA is seeking a Senior Quality Manager-Advanced Imaging to lead the QMS and design assurance across the product lifecycle. You will guide regulatory readiness, oversee audits, and drive continuous improvement in a regulated medical device environment.

The role requires 8+ years in FDA-regulated medical devices, strong leadership, and a Bachelor's in Quality or Engineering. Office-based role with on-site presence in Bedford, MA.

Qualifications

• 8+ years in FDA regulated medical device environments with focus on QMS compliance and design assurance.
• Proven experience managing quality teams, budgeting, workforce planning, and coaching.
• Strong knowledge of ISO 13485/14971, 21 CFR 803/806/820, EU MDR, GMP, GDP.
• Experience leading audit readiness and regulatory inspections.
• Minimum Bachelor's Degree in Quality, Engineering, or similar.

Responsibilities

• Lead the Quality functions as a strategic member of the leadership team, fostering a culture of quality, compliance, and continuous improvement.
• Oversee the QMS to ensure compliance with FDA QMSR, ISO 13485, MDR, and other regulatory requirements.
• Serve as primary quality representative for regulatory inspections and audits with authorities and notified bodies.
• Establish and continuously improve quality processes, systems, and procedures for safe and high-quality products.
• Lead and develop the quality organization through talent acquisition, performance management, and training.
• Monitor quality metrics and drive data-driven improvement initiatives.
• Partner with R&D, Operations, Regulatory Affairs to resolve quality issues and execute quality strategies.
• Oversee design assurance activities including design controls, V&V, design transfer, and process validation.

Skills

QMS

Regulatory Audits

Leadership

Cross-functional

Education

Bachelor's Degree in Quality/Engineering

Job description

Philips in Bedford, MA is seeking a Senior Quality Manager-Advanced Imaging to lead the QMS and design assurance across the product lifecycle. You will guide regulatory readiness, oversee audits, and drive continuous improvement in a regulated medical device environment.

The role requires 8+ years in FDA-regulated medical devices, strong leadership, and a Bachelor's in Quality or Engineering. Office-based role with on-site presence in Bedford, MA.