Director, Quality & Compliance-Image Guided Therapy Devices

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 andcompliance 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 many 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% This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. #J-18808-Ljbffr Regulatory Jobs