Director, Quality Programs (PMO)-Ambulatory Monitoring & Diagnostics

Philips•Phoenix, AZ

23h•$162,000 - $270,000•Hybrid

About The Position

The Director, Quality Programs (PMO)-AM&D is responsible for strategic leadership and execution of global quality vision, by leading critical quality programs and coordinating activities across multiple disciplines, ensuring alignment with business objectives and regulatory requirements. provides strategic leadership in driving critical quality/compliance programs associated with Quality Management Systems (QMS)-QMS implementation, PQMS changes/transitions, and continuous improvement/transformation programs. Your role: Provides strategic guidance to managers in different areas, identifying opportunities for quality improvement and innovation, and fostering a culture of quality excellence and continuous improvement throughout the organization. Tackles complex issues by analyzing situations with a deep understanding of the organization, contributing to the development and refinement of organizational objectives and principles to drive effective solutions. Ensures the overall regulatory submission process for product compliance, ensuring compliance with applicable regulations such as FDA, EU-MDR, and other regulatory requirements such as ISO13485, 21 CFR 820, and maintains consistent guidelines and policies across all products and operations. Enforces robust regulatory processes and harmonize them across functions, establishing a comprehensive management review process, including routine reporting on regulatory compliance activities to maintain organizational awareness. Assists in succession planning and comprehensive talent management, supporting employee selection, performance management, compensation management, and career development in alignment with organizational operational goals. Demonstrates leadership experience in at least one operating process domain, such as product development or supply chain, and various aspects of quality, showing familiarity with business process management frameworks and regulatory strategy development. Identifies and evaluates fundamental issues within the functional area, interact with executive-level management, and oversee activities such as planning, staffing, budgeting, managing expense priorities, and proposing methodological changes to improve efficiency and effectiveness. May include Person Responsible for Regulatory Compliance (PRRC) responsibilities such as verifying compliance of devices with regulations, maintaining technical documentation, overseeing post-market surveillance system for effective data collection for maintenance of device safety and performance and fulfillment of vigilance reporting obligations, and sign statements confirming that investigative devices comply with general safety standards. Will plan, manage, execute, and be responsible for program timeliness, supporting key stake holders across Product manufacturing sites and central Philips entities. Responsible for ensuring program objectives are determined, achieved, communicated with management and product owners, integration of multiple functions is facilitated, logistics are effectively coordinated, and budgets are adhered to.

Requirements

Minimum of 10+ years’ experience leading full-cycle, global Quality Programs within FDA regulated medical device Manufacturing /Supply Chain environments, with a focus on Quality Management Systems (QMS), including ISO 13485 QMS implementation/transitions, CAPA processes, Nonconformance, Process Controls, etc.
Highly experienced in all aspects of E2E global Program Management including 5+ years in strategic/cross-functional leadership, change/risk management, KPI’s, budgeting, timelines, resource allocation, project/quality strategy, reporting, communication, etc.
Demonstrated experience leading and implementing quality management system processes and tools such Change/Management Controls, Training programs, Audit/ non-conformance processes such as CAPA programs, and systemic improvements across businesses and manufacturing sites.
Detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
Proven experience utilizing data analytics/ Quality KPI’s to assess project/program/team performance and identify process/continuous improvement and Remediation opportunities.
Able to effectively communicate, influence and build relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and manage/facilitate FDA, competent authorities, Regulatory Agencies and Notified Body audits and inspections.
Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Lean/ Six Sigma and ASQ-CQM certifications desired.

Responsibilities

Provides strategic guidance to managers in different areas, identifying opportunities for quality improvement and innovation, and fostering a culture of quality excellence and continuous improvement throughout the organization.
Tackles complex issues by analyzing situations with a deep understanding of the organization, contributing to the development and refinement of organizational objectives and principles to drive effective solutions.
Ensures the overall regulatory submission process for product compliance, ensuring compliance with applicable regulations such as FDA, EU-MDR, and other regulatory requirements such as ISO13485, 21 CFR 820, and maintains consistent guidelines and policies across all products and operations.
Enforces robust regulatory processes and harmonize them across functions, establishing a comprehensive management review process, including routine reporting on regulatory compliance activities to maintain organizational awareness.
Assists in succession planning and comprehensive talent management, supporting employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.
Demonstrates leadership experience in at least one operating process domain, such as product development or supply chain, and various aspects of quality, showing familiarity with business process management frameworks and regulatory strategy development.
Identifies and evaluates fundamental issues within the functional area, interact with executive-level management, and oversee activities such as planning, staffing, budgeting, managing expense priorities, and proposing methodological changes to improve efficiency and effectiveness.
May include Person Responsible for Regulatory Compliance (PRRC) responsibilities such as verifying compliance of devices with regulations, maintaining technical documentation, overseeing post-market surveillance system for effective data collection for maintenance of device safety and performance and fulfillment of vigilance reporting obligations, and sign statements confirming that investigative devices comply with general safety standards.
Will plan, manage, execute, and be responsible for program timeliness, supporting key stake holders across Product manufacturing sites and central Philips entities.
Responsible for ensuring program objectives are determined, achieved, communicated with management and product owners, integration of multiple functions is facilitated, logistics are effectively coordinated, and budgets are adhered to.