Senior Quality Manager-Advanced Imaging

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

Benefits offered by this job

Paid time off (PTO)

401(k) match

Health savings account (HSA)

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Quality Manager-Advanced Imaging to lead the Quality Management System and Design Assurance across the product lifecycle of Image Guided Therapy products. You will drive a culture of quality, compliance, and continuous improvement while partnering with R&D, Operations, and Regulatory Affairs.

The role requires 8+ years in FDA-regulated medical devices, strong QMS and regulatory knowledge, and experience leading audits and CAPA programs.

Qualifications

• Minimum 8+ years in FDA-regulated medical device environments with QMS and Design Assurance focus.
• Proven management of quality teams, budgeting and workforce planning.
• Strong knowledge of ISO 13485, 21 CFR 803/806/820, EU MDR, GMP, GDP.
• Experience leading audits, regulatory inspections, and CAPA programs.
• Experience applying KPI and data analysis to drive improvements.

Responsibilities

• Lead Quality functions as a strategic member of the leadership team.
• Oversee QMS compliance with FDA QMSR, ISO 13485, MDR and regulatory requirements.
• Serve as primary quality representative for inspections and external audits.
• Improve quality processes, systems, and product quality across lifecycle.
• Lead and develop a high-performing quality organization and talent.
• Monitor quality metrics and drive data-based decisions and improvements.
• Partner with R&D, Operations, Regulatory Affairs to resolve quality issues.
• Oversee design controls, verification/validation, design transfer, and process validation.
• Apply risk management across development, manufacturing, and post-market.
• Lead investigations, CAPA, nonconformance, and corrective actions.
• Incorporate customer feedback and post-market data to improve safety and compliance.
• Drive audit readiness and responses to internal and regulatory audits.

Skills

Quality management

Regulatory compliance

QMS leadership

Design assurance

Audits & inspections

CAPA & root cause

Risk management

Leadership & people mgmt

Education

Bachelor's Degree in Quality or Engineering

Job description

Senior Quality Manager-Advanced Imaging

Job Description

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 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%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.