Senior Quality Manager-Advanced Imaging

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

Senior Quality Manager-Advanced Imaging

The Senior Quality Manager-Advanced Imaging provides leadership for the Quality Management System (QMS) and Design Assurance functions, ensuring the delivery of safe, effective, and compliant Image Guided Therapy products throughout the product lifecycle.

Your role:

• Lead the Quality functions as a strategic member of the leadership team, fostering a culture of quality, compliance, and continuous improvement across the organization.
• Provide oversight of the Quality Management System (QMS), ensuring compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), and other regulatory requirements.
• Serve as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies.
• Establish, maintain, and continuously improve quality processes, systems, and procedures to ensure the delivery of safe, effective, and high-quality products.
• Lead and develop a high-performing quality organization through effective talent acquisition, performance management, coaching, succession planning, and employee development.
• Monitor and analyze quality system and product performance metrics, driving data-based decision making and strategic improvement initiatives.
• Partner cross-functionally with R&D, Operations, Regulatory Affairs, and other functions to resolve quality issues, support business objectives, and ensure effective execution of quality strategies.
• Oversee design assurance activities throughout the product lifecycle, including design controls, verification, validation, design transfer, and process validation.
• Ensure robust application of risk management principles across product development, manufacturing, and post-market activities to proactively identify and mitigate risks.
• Lead complex investigations, root cause analyses, CAPA activities, nonconformance management, and corrective actions to drive sustainable quality improvements.
• Integrate customer feedback, reliability data, and post-market surveillance insights to enhance product quality, safety, performance, and regulatory compliance.
• Drive audit readiness across the organization and ensure timely, effective responses to internal audits, regulatory inspections, and external assessments.
• Lead strategic quality and operational excellence initiatives utilizing quality engineering, Lean, Six Sigma, and other continuous improvement methodologies.
• Establish and manage departmental objectives, budgets, resource plans, and performance goals to ensure efficient and effective execution of quality responsibilities.

You're the right fit if:

• You have a minimum of 8+ years’ experience in FDA regulated medical device environments, with a focus on Quality Management System (QMS) Compliance, and Design Assurance functions.
• You have proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have extensive experience managing design assurance activities throughout the product lifecycle, including design controls, Risk Management (ISO 14971, DFMEA/PFMEA) V&V, design transfer, and process validation.
• You have extensive experience in leading audit readiness, serving as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies and ensuring timely, effective responses to internal audits, regulatory inspections, and external assessments.
• You have proven experience utilizing Quality KPI’s/Data Analysis to assess project/team performance and identify process and continuous improvement opportunities.
• You have extensive experience leading CAPA/Nonconformance activities, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Bedford, MA is $134,000 to $213,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the