Director of Quality and Compliance

Philips•San Diego, CA

1d•$162,000 - $288,000•Onsite

About The Position

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. This role involves leading, managing, and developing the Image Guided Therapy Devices (IGTD) quality systems team, driving an inclusive, supportive environment and strong employee engagement. The position is responsible for ensuring the effective operation and evolution of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, industry standards, and internal policies. This includes compliance of PDLM and manufacturing processes, execution of change management, internal/external audit processes, CAPA processes, and management of Quality system KPIs and objectives. The Director will act as an advisor to senior leadership on all quality-related matters, formulating and implementing the Business’ strategic vision for QMS programs aligned with business objectives, ensuring quality systems support the organization’s goals. Additionally, the role enforces the simplification/harmonization of quality systems across Business sites/sectors, establishes an effective Management Review process, routine reporting, and introduces/implements necessary quality processes/tools to ensure product quality and customer satisfaction. The Director will also serve 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.

Requirements

Minimum of 10+ years' experience in global, FDA regulated medical device environments.
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).
Experienced in utilizing, monitoring KPI’s to assess the performance of the team and QMS to drive high performance/process improvement.
Well versed in business process management frameworks, including industry best practices related to FDA regulated QMS.
Proven expertise/knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR for all classifications of medical devices.
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.
Minimum of a Bachelor's degree in Quality, Life Sciences, Engineering or similar technical discipline-REQUIRED.
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

Master's degree in business, management or quality, strongly preferred.

Responsibilities

Lead, manage and develop the Image Guided Therapy Devices (IGTD) quality systems team, driving an inclusive, supportive environment and strong employee engagement.
Ensure 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).
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.
Enforce 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.
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.