QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.Manage day-to-day Quality Control functions includingQuality Control: scheduling of inspections, line support and testingDocument Control: management of all pertinent data basesQuality 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 leads systems improvements project teams as requiredMeet with production management on 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 processesBachelor's in engineering or Sciences.5+ years' quality experience in related field within medical industry environment3+ years management experience - solid leadership and influential partnership skillFully 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 preferredManages 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 guidelinesManages 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 involves resolution of issues related to operations and/or projectsGains consensus from various parties involvedCandidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background.
We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
