Philips Director-Global Quality Programs 

United States, Washington, Bothell 

312174166

Your role:

• Leads and directs all aspects of Global quality operations/assurance program activities, including Emergency Care business separation/divestiture quality transformation, including strategy design/development, execution oversight, independent assessment, and compliance by design initiatives, compliance management, and capability building, to ensure adherence to quality standards and continuous improvement across the organization.
• Will contribute to strategic planning involving mission, vision, and policies to ensure alignment and effectiveness in organizational decision-making and adaptability.
• Supports supplier/3rd party qualification, audits, and assessment process, supports external/internal audits, aids in regulatory compliance gap closure, operational quality metrics, agreements, and records, and participates in operational quality-related communication and feedback.
• Develops and executes requirements, conditions, and enablers within the Emergency Care business and ensures that all products released adhere to pertinent safety and environmental regulations, guaranteeing compliance and upholding standards.
• Leads planning, staffing, budgeting, expense management prioritization, and drive proposals and implementations of methodological changes to ensure organizational efficiency and effectiveness.
• Establishes a supply chain quality assurance practice at the delivery model level, oversees and ensures the performance of teamwork within the defined scope per delivery model, and maintains responsibility for regulatory compliance of Emergency Care sites within their jurisdiction.
• Manages and monitors quality compliance issues and conflict resolution and leads cross-functional discussions to determine adequate resolutions that support business needs.
• Supports product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the recall process to maintain compliance and uphold consumer safety.
• Acts as the senior-level manager, possesses broad expertise and unique knowledge, shapes company objectives and principles, contributes creatively and effectively towards goal attainment, and is recognized as an expert both within the company and the industry.

You're the right fit if:

• You’ve acquired a minimum of 10 years’ experience in Quality Operations/Supply Chain Assurance within FDA regulated (ISO 13485) medical device environments. Product experience with AED’s/Defibrillators or other Class III Devices containing medical electrical equipment/software highly desired.
• You have proven experience leading global Quality Operations/Supply Chain Assurance programs and transformational initiatives, with experience in Business/Organizational separations/divestitures highly preferred.
• You’ve acquired extensive experience and knowledge of global medical device regulations, guidance, and applicable standards including ISO 14971, ISO 13485, 21CFR 820, EU MDR.
• You have a proven track record of working/communicating effectively with Global cross-functional teams and with internal/external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
• You have a Minimum of a Bachelor’s Degree (Required) in a Quality discipline, Supply Chain Management, Engineering, Clinical/Life Science or similar disciplines. Master’s Degree desired. ASQ Certifications desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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.

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Philips Transparency Details:

• The pay range for this position in Bothell, WA is $172,000 to $275,000.

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 Bothell, WA.
• May require travel up to 40%.