QA Engineering Supervisor - Tijuana, México - Cardinal Health
Descripción
_Main Responsibilities _
- Act as regulatory expert for the functional teams in the execution of change management and validations activities for products, process, materials and software.
- Support and guide from the QA Engineering perspective all activities related with projects that impact the facility, the product and the manufacturing operation (VIPs, cost saving, continues improvement)
- Lead the Risk Management Process for the manufacturing site and products under responsibility. Ensure decisionmaking based on risk for the process and products
- Support and guide the team in product and process investigations arising from manufacturing, processes, facilities, suppliers, materials, as well as complaints and nonconformities of audits and inspections
- Direct responsible for the handling of the nonconforming product and the entire process to be followed for the adequate disposal and retention based on the applicable procedures and regulations
- Support and direction in transfer projects and new products to ensure in compliance and effectiveness during the execution
- Assess trends in products and processes to active the corrective and preventive actions when it is applicable. As well, the development of plans as part of the continuous improvement.
- Ensures all processes and procedures developed and under their responsibility comply with the quality system, corporate policies, regulations, and any other applicable requirements.
- Ensures projects are completed on time and within budget
- Assists the quality research and development team in ensuring proper implementations in the applicable process and products
- Assists the Site Quality Manager with the Product Corporate Holds and all the activities and information required for the distributed product analysis
- Development and management of quality engineers to ensure compliance with activities, their knowledge and growth.
- Lead the continuous improvement projects of the department focused on the quality of the product, the patient the efficiency and cost.
_ Qualifications_
- At least bachelor degree in a Engineering Field or similar
- +3 years of experience leading personal
- Advanced English
- Demonstrate experience in ISO13485, FDA QSR, and all applicable regulations for MDSAP
_ What is expected of you and others at this level_
- Coordinates and supervises the daily activities of operations, or business support staff
- Administers and executes policies and procedures
- Ensures employees operate within guidelines
- Decisions have a direct impact on work unit operations and customers
- Frequently interacts with subordinates, customers and peer groups at various management levels
- Interactions normally involve information exchange and basic problem resolution
- 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._
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