What QRA Management contributes to Cardinal Health QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function. Accountabilities Manage day-to-day Quality Control functions includingQuality Control: scheduling of inspections, line support and testingDocument Control: management of all pertinent databasesQuality related audits and certificationsPartners with site Director and managers to recruit, hire, develop/supervise and train Quality Control and Document Control personnel including performance reviews in accordance with Departmental and Corporate practicesDefine, communicate and enforce quality policies focused on CAH and external compliance and regulatoryCoordinate QRA functions and activities between departments. Determine responsibilities and procedures for ensuring that this function is performed effectively, and objectives are achievedParticipate and assist in the formulation and establishment of organizational policies and quality procedures for the Quality Control departmentParticipate and lead systems improvements project teams as requiredMeet with production management on a regular basis and support goals outlined in the company's operating planBudgeting, planning and resource evaluation in line with Zero Base Management initiativesDevelop strategies to implement Quality system regulations and continuously improve Quality processesQualifications (minimum requirements) Bachelor's in engineering or Sciences.5+ years' quality experience in related field within medical industry environment3+ years management experience - solid leadership and influential partnership skillsFully bilingual English / Spanish.Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulationsExperience in product manufacturing transfers, facility/line startup, etc.Experience in product design and transfer processes USA to MEX or similarExperience managing external Regulatory Agency compliance audits (FDA, ISO13485) highly preferredAbility to travel up to 20%Kaizen, Six Sigma Certification highly preferredWhat is expected of you and others at this level Manages department operations and supervises professional employees, frontline supervisors and/or business support staffParticipates in the development of policies and procedures to achieve specific goalsEnsures employees operate within guidelinesDecisions have a short-term impact on work processes, outcomes, and customersInteracts with subordinates, peer customers and suppliers at various management levels; may interact with senior managementInteractions normally involve resolution of issues related to operations and/or projectsGains consensus from various parties involved
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