Director of Quality and Compliance

## Director of Quality and Compliance Apply locations:
Plymouth, Minnesota, United States:
San Diego, California, United States:
Colorado Springs, Colorado, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
587271### Job Title Director of Quality and Compliance###

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, ISO
13485, ISO
14971, 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:
**…