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.

Youre 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/CFR (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 KPIs/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 Bachelors 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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 $134000 to $213000.

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%.

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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.