Descripción del Trabajo
The Director Supplier Quality Management is responsible for the implementation and execution of the organization’s Supplier Quality Management System for the Medical Division in alignment with the organization’s global policies/procedures and compliance with medical device quality systems (Specifically ISO 13485 and CFR 820). As a member of Divisional Quality Team, be responsible for supplier assessment, selection and development from a supplier quality perspective. He/She will create, implement and monitor supplier development initiatives including supplier qualification, supplier selection, on-going supplier performance management & reviews, process improvements and audits.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Develop and communicate organization’s expectations for quality performance, continuous improvement, quality systems, process controls and capabilities to suppliers.
· Lead the supplier qualification program assessing compliance of suppliers with cGMPs and other regulatory requirements as well as global and divisional policies, standards & procedures.
· Develop and sustain strong relationships with suppliers.
· Conduct supplier risk assessments for key/strategic new and approved suppliers.
· Manage and maintain qualification status for existing/approved suppliers.
· Development of supplier audit schedule. Conduct supplier quality audits to determine adherence to acceptable quality regulations and requirements. Issue audit observations, development plan(s) and follow-up with suppliers on audit observations to ensure follow through.
· Measure, track, trend and communicate/report supplier performance on key metrics and the corresponding continuous improvement plans on a regular (monthly/quarterly) basis.
· Mentor and coach supplier quality engineers in best practices in supplier quality systems, process controls, problem solving and statistical tools.
· Ensure and manage robust process and system for communicating, planning and executing major supplier-initiated changes, complaints and deviations.
· Lead major/multiple site impacting investigations and resolution of issues with suppliers.
· Ensure robust processes, procedures and systems for storing/retrieving all critical supplier related interaction/documents from qualification through retirement.
· Ensure strong processes, master data and systems so all required purchased go through qualified suppliers.
· Harmonize SOPs, master specifications and testing where applicable.
· Lead the divisional supplier quality management organization, including identification of resources required, recruiting, supervision, training and employee development.
· Establishment and achievement of divisional goals for supplier performance and compliance.
· Contribute to the development and implementation of sourcing and supplier strategy as well as supplier selection.
· Develop strong relationships with internal partners that enable swift and beneficial contract negotiations with quality and risk mitigation plans.
· Act as an opinion leader in the promotion of supplier quality management ideals, concepts and practices through the Jabil Medical division and suppliers network.
· May perform other duties and responsibilities as assigned.
· Demonstrated ability to manage and lead a global workforce.
· Experience and demonstrated success of working across cultures.
· Demonstrated track record of effectively influencing without authority with all levels of an organization and leading effective/successful change initiatives.
· Excellent oral/written communication skills.
· Strong experience in development of business process and procedures.
· Strong analytical and statistical problem solving tools.
· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
EDUCATION & EXPERIENCE REQUIREMENTS
· BS degree or equivalent in Business Management, Engineering, or other related field of study.
· Technical degrees preferred.
· Minimum 8-10 years of experience in quality management and leadership, including quality systems, standards, metrics, tools and
· Mastery of medical device quality systems (specifically ISO13485, CFR Part 820) and applications is required.
· Experience in launching medical device products with software & electronic components.
· Or an equivalent combination of education, training or experience