Gerente de Calidad

What Quality Management contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

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. :

• Demonstrates 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, statistical methods to facilitate process analysis and improvements. :

• Understands product design, design transfers, and production 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, and product risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting. :

• Experience with performing process validations (IQ/OQ/PQ), equipment qualification, and test method validations. :

• Strong communication skills (written and verbal); ability to present communication plans and status updates to customers : Qualifications :

• Bachelors in Engineering, related field, or equivalent work experience in focused area. :

• 8+ years QRA experience in related field within medical device manufacturing :

• Solid leadership and mentorship experience :

• Advance English and Spanish (read, write, speak) :

• Proven experience within a medical device manufacturing environment (ISO13485) :

• 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). :

• Experience in project management and 6 Sigma process improvement methodologies. Kaizen, or Black Belt certification preferred. :

• Demonstrated knowledge and experience with FDA’s product Design Control process and design/product transfers. :

• Strong understanding of statistics, statistical theory, and statistical analysis :

• Strong understanding of business unit function and cross group dependencies/relationships. : What is expected of you and others at this level **:

• Manages department operations and supervises professional employees, frontline supervisors and/or business support staff :

• Participates in the development of policies and procedures to achieve specific goals :

• Ensures employees operate within guidelines :

• Decisions have a short term impact on work processes, outcomes, and customers :

• Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management :

• Interactions normally involves resolution of issues related to operations and/or projects :

• Gains consensus from various parties involved :

• 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._