Title: Latin America Quality Director
Location: BR-SP-São Paulo
Job Number: QUA101B4
1. Responsible for leading and/or facilitating the Latin America Leadership Team in the development of a robust and integrated Strategic Quality Plan, which defines the quality practices, resources, and activities relevant to products that are storage and sold within the Region. The Plan shall also establish how the requirements for quality will be met, with strong attention to developing and maintaining high performing underlying processes while also developing highly flexible or adaptive approaches where needed, yet managed under disciplined review. Responsibility includes assuring that the Quality Plan is updated, as needed, to reflect any changed business/customer needs or regulatory requirements and, that appropriate procedures are in place for the review and approval of such changes to the Quality Plan.
2. Responsible for the development and continuous improvement of the Quality Management function and associates to the highest professional and performance standards. The Director, Quality Management will promote and develop Diversity as a key element of high performance.
3. Responsible to address issues, influence decisions as well as deliver QLT strategies within LA Region
4. The Director, Regional Quality is responsible to evolve system and culture foster a problem prevention focus
5. Responsible to Re-brand quality to emphasize its most valuable focus on operation excellence and productivity, employing visual aids to bring quality into daily view and continuously instill it within the common worker’s mindset, communicating Quality Objectives, clearly, consistently and continuously.
6. The Director, Regional Quality must instill a Process Management competency and discipline in the Region and QM function, such that ir can effectively align with an support the BD strategy and goals for Operational Effectiveness, Talent Development, Regulatory Compliance, etc… As such , the Director, Regional Quality must effectively communicate and collaborate with BD process Owners and other leaders of BD or One Company Initiatives and Programs to effectively represent the Quality Management interests and needs of their business and it’s customers. For example, the Director, Regional Quality may serve in this capacity on the QSC, GSCC or similar bodies.
7. Responsible through Quality System and Quality & Regulatory Managers for managing and facilitating the Management Review process in each hub, is, that Management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures and, that any improvements or changes in the quality system at DC’s and CMC are implemented and documented.
8. The Director, Quality Management shall be a member of the Company Quality Leader Team, functionally reporting to the VP, Corporate Quality Management. The Company Quality Leader Team collaborates and supports each other in development and implementation of quality initiatives, programs, systems and best practices, which support the BD Enterprise strategy and goals. Such initiatives include Six Sigma and Lean in DC’s as well as business processes, and, the continual improvement/optimization of elements of the Quality System beyond basic regulatory compliance to provide greater value to the business and it’s customers. It is important for the Director; Regional Quality to actively participate on this one company team to leverage the Team’s combined leadership and resources to drive internal performance and customer perceived quality.
9. Responsible for assuring that all Quality Management function associates are trained to adequately perform their assigned quality responsibilities.
10. Other or more specific responsibilities include:
o Responsible, through a Quality System and Quality and Regulatory Managers the management of Quality System Documentation Management and Engineering Change Control (ECO) systems per BD Policies & Guidance as well as, the implementation and maintenance of Quality System at DC’s.
o Responsible through a CMC, support of complaints handling and trending as well as recall of non conforming materials, adverse reporting.
o Responsible through a Quality System and Quality and Regulatory Managers budget development and administration, including input/review to assure adequate resourcing for Quality System responsibilities and quality function support of the business Quality Plan.
o Support through a Quality System and Quality and Regulatory Managers, in collaboration with Operations, Regulatory Compliance and other responsible management and functions, of a BD Corrective/Preventive Action System and, direct responsibility for prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements.
o Ensure good and on time communication with Regional, Corporate and Quality Business Leaders, regarding Quality related topics.
o Lead ,facilitate and support Regional and Corporate Projects
o Lead and facilitate change management process looking for prevention and CI Culture/ foundation.
o Act as an agent of change supporting the design, integration and implementation of company wide change initiatives.
o Identify, understand and manage interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving it’s objectives aligned with Key Business drivers and setting project goals.
o Embed Quality and CI into the Business and Process Improvement efforts to impact Business Bottom line and looking for sustainability/growth of the Business.
o Ensure that both internal and external customer expectations are identified, prioritized and either met or exceeded.
o Look for a comprehensive management approach to align Business processes to Corporate, and Region strategy, to analyze, optimize and implement best in class processes.
o Implement performance measures and communication plan within the LA Region to show progress and/or point the way for improvement in order to drive business excellence.
Qualifications:
EDUCATION:
Minimum education required to perform duties
BS Degree/Master’s Degree or higher preferred. MBA desirable.
BB (Certified Master Black Belt preferred) in Manufacturing or
Transactional Six Sigma, DFSS or equivalent in ASQ desirable.
Experience:
Minimum years required both inside and outside company, to perform duties.
Five years experience in Quality Management at the Director or VP level in the medical device/healthcare industry, and at least ten years Quality Management or Process Improvement experience in other manufacturing and/or service industries, which are recognized for supply chain excellence, design excellence and customer focus.
Job: Qualidade