Director, Quality & Compliance-Image Guided Therapy Devices

Philips International; Plymouth (MA); On-site; USD 170,000 - 270,000; Full time

Job summary

Philips seeks a Director of Quality & Compliance for Image Guided Therapy Devices to lead the IGTD quality systems team, harmonize processes and drive regulatory compliance across global sites.

You will ensure a robust QMS, oversee CAPA, change management and internal/external audits, report KPIs to senior leadership, and shape strategy to align quality with business goals. This role requires tenacity, collaboration and a track record of delivering measurable quality improvements.

Qualifications

• 10+ years experience in global FDA‑regulated medical device environments.

Responsibilities

• Lead, manage and develop the Image Guided Therapy Devices quality systems team across sites.

Skills

Leadership

Quality Management

QMS Implementation

CAPA

Change Management

Audits (Internal)

Audits (External)

Regulatory Knowledge

KPI Tracking

Cross-functional Collaboration

Education

Bachelor's degree in Quality, Life Sciences, Engineering or similar

Master's degree in business, management or quality

Job description

Job Title Director, Quality & Compliance-Image Guided Therapy Devices

Job Description

The Director of Quality & Compliance plays an important leadership role within Philips’ Image Guided Therapy Devices quality organization, focused on Quality system harmonization/simplification, the introduction/implementation of quality processes/tools, FDA/Notified body compliance and effective Management Review processes/reporting.

Your role: You will lead, manage and develop the Image Guided Therapy Devices (IGTD) quality systems team, driving an inclusive, supportive environment and strong employee engagement.

You’re Responsible for ensuring the effective operation/evolution of the Quality Management System (QMS), ensuring the QMS is compliant with the applicable regulatory requirements, industry standards and internal policies (inclusive of compliance of PDLM and manufacturing processes and execution of change management, internal /external audit process, CAPA process, and management of Quality system KPIs and objectives).

You will act as advisor to senior leadership on all quality related matters, formulating/implementing the Business’ strategic vision for QMS programs aligned with the business objectives (long-range quality, regulatory and compliance policy), ensuring that quality systems support the organization’s goals.

You will be responsible for enforcing the simplification/harmonization of quality systems across the Business sites/sector; establish an effective Management Review process, routine reporting and introduce/implement the quality processes/ tools required to ensure product quality and customer satisfaction.

You will act as the quality representative on the Business Category Leadership Team, providing strategic quality leadership and partnering cross-functionally to shape and execute category strategy, proactively resolve business and quality challenges, drive operational excellence, and ensure quality objectives are integrated into key business decisions.

You're the right fit if: You’ve acquired a minimum of 10+ years' experience in global, FDA regulated medical device environments, including proven functional and strategic leadership of diverse quality teams in various aspects of Quality, including, quality systems/QMS implementation, simplification, standardization, CAPA, Change Management and internal/external audit for multi-site businesses in a large, multi-national, global/matrix organization (s). You’re experienced in utilizing, monitoring KPI’s to assess the performance of the team and QMS to drive high performance/process improvement and well versed in business process management frameworks, including industry best practices related to FDA regulated QMS. You have proven expertise/knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR for all classifications of medical devices. You are a highly collaborative, strategic leader, influencer, with strong experience in change management and ability to effectively communicate/build relationships with internal/external stakeholders and at all levels of the organization You have a minimum of a Bachelor's degree in Quality, Life Sciences, Engineering or similar technical discipline-REQUIRED, Master's degree in business, management or quality, strongly preferred. 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-Based 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 of 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 Colorado Springs, CO is $162,000 to $258,000. The pay range for this position in Plymouth, MN is $170,000 to $270,000. The pay range for this position in San Diego, CA is $181,000 to $288,000. 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. 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. 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 Colorado Springs, CO, Plymouth, MN or San Diego, CA. This role 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.

Equal Employment and Opportunity

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.