Ingeniero Principal de Calidad, UL/ESD/IEC standards

Company: Cardinal Health
Location: Hialeah
Posted on: May 3, 2021

Job Description:

What Quality Engineering contributes to Cardinal HealthQuality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation ofprevention-basedmethodologies used in design, manufacturer, test, sustainability and correction of products and services.Focus: This role will be accountable of quality activities related to the productduring manufacturing,once it leaves the production lineand manufacturing site, as well as during post market surveillance. The QA Engr will liaise with various departments across the organization to ensure product quality in the areas ofproduct design, risk management,manufacturing, packaging,sterilization, andshipment and delivery to our distribution centers.Qualifications (Minimum requirements)Bachelor's Degree inEngineering(electromechanical) AND/OR Bachelor's Degree in Quality Assurance or Industrial Engineering with in-depth experience in electromechanical med device.4+years' experiencein electromechanical medical device manufacturing environment or similar.Advance proficiency in English(verbal and written).Knowledge and experience manufacturing of electromechanical medical devices, ESD, UL, and IEC 601-1 standard requirements.Demonstrated knowledge of medical device and governmental regulations and standards (21 CFR Part 820, ISO13485, MDR).Knowledge and experience of medical device risk management standards (ISO14971).Demonstrated knowledgeand experience with FDA's product Design Control process and design/product transfers.Experience in project management and6 Sigmaprocess improvementmethodologies. Strong understanding of statistics, statistical theory, and statistical analysisStrong understanding of business unit function and cross group dependencies/relationships.Solid ability to easily create partnerships with internal customers.Self-starter, proactive, adaptable and engaging approach.Kaizen,or Black Beltcertificationpreferred.Travel to the USA required - US Visa preferred.AccountabilitiesDemonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.Develops and implements quality programs and process improvement initiatives to ensure compliance of final product quality standards and delivery.Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.Acquires and analyzes data using appropriate standard quantitative, statisticalmethods to facilitate process analysis and improvements.Understandsproduct design, design transfers, andproduction line quality standards, i.e., controls, process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.Demonstrates knowledge of reliability, maintainability, andproductrisk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.Experience with performingprocessvalidations (IQ/OQ/PQ),equipmentqualification, andtest method validations.Strong communication skills (written and verbal); ability to present communication plans and status updates to customersWhat is expected of you and others at this levelApplies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasksExercises judgement in selecting innovative, practical methods to achieve problem resolution.May lead a project team. Participates in determining goals and objectives for projectsof moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes actions to resolveInfluences management on technical or business solutions.Applies judgment within defined parametersPlans and organizes non-routine tasks and establishes priorities of work assignments with approval. Receives general guidance may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyMay provide work direction and guidance to exempt and/or skilled nonexempt levels of employees.Ability to presentproject status by preparing standard status report and by participating in departmental and customer project update meetings.Relocation assistance provided.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.

Keywords: Cardinal Health, Hialeah , Ingeniero Principal de Calidad, UL/ESD/IEC standards, Other , Hialeah, Florida