Senior Quality Manager-Advanced Imaging

Philips International; Tennessee; On-site; USD 134,000 - 213,000; Full time

Job summary

Philips seeks a Senior Quality Manager‑Advanced Imaging to lead the Quality Management System (QMS) and Design Assurance for safe, compliant Imaging products throughout the lifecycle.

You will drive regulations compliance (FDA QMSR, ISO 13485, MDR), lead audits, and build a high-performing quality organization through coaching, succession planning, and data-driven improvements.

Qualifications

• Minimum 8+ years in FDA regulated medical device environments with QMS compliance and design assurance.
• Strong management of quality teams, budgeting, workforce planning, coaching, and succession planning.
• Extensive knowledge of ISO 13485/14971, 21 CFR 803/806/820, MDR/MDD, GMP and GDP.

Responsibilities

• Lead the QMS and Design Assurance functions across the product lifecycle.
• Oversee regulatory inspections, external audits, and interactions with authorities/notified bodies.
• Drive CAPA, nonconformance, root cause analysis and corrective actions.
• Lead data-driven decisions through Quality KPIs and performance metrics.
• Partner with R&D, Operations, Regulatory Affairs to resolve quality issues and execute quality strategies.

Skills

QMS compliance

Design Assurance

Regulatory inspections

Quality KPI / Data analysis

CAPA / Nonconformance

Leadership / people management

Cross-functional collaboration

Risk management (ISO14971)

Auditing experience

FDA-regulated medical devices

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 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 top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long‑term incentives may be offered.

Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa, now or in the future. Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA. May require travel up to 10%.

Equal Employment and Opportunity Statement

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. At Philips, we believe that every human matters. As a global health‑tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we’re taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888‑367‑7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.