Quality Assurance Supervisor
hace 2 semanas
Job Summary
We are seeking a highly skilled Quality Assurance Supervisor to join our team at Cardinal Health. As a Quality Assurance Supervisor, you will be responsible for managing product and service quality planning, evaluation, and control. You will work cross-functionally with various teams to develop and implement prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
Main Responsibilities
- Act as regulatory expert for functional teams in the execution of change management and validations activities for products, processes, materials, and software.
- Support and guide QA Engineering activities related to projects that impact the facility, product, and manufacturing operation.
- Lead the Risk Management Process for the manufacturing site and products under responsibility.
- Support and guide the team in product and process investigations arising from manufacturing, processes, facilities, suppliers, materials, complaints, and nonconformities of audits and inspections.
- Directly responsible for handling non-conforming product and the entire process to be followed for adequate disposal and retention based on applicable procedures and regulations.
- Support and direction in transfer projects and new products to ensure compliance and effectiveness during execution.
- Assess trends in products and processes to activate corrective and preventive actions when applicable.
- Develop plans as part of continuous improvement.
- Ensure all processes and procedures developed and under responsibility comply with the quality system, corporate policies, regulations, and any other applicable requirements.
- Ensure projects are completed on time and within budget.
- Assist the quality research and development team in ensuring proper implementations in applicable processes and products.
- Assist the Site Quality Manager with Product Corporate Holds and all activities and information required for distributed product analysis.
- Development and management of quality engineers to ensure compliance with activities, their knowledge, and growth.
- Lead continuous improvement projects of the department focused on the quality of the product, patient, efficiency, and cost.
Qualifications
- Bachelor's degree in an Engineering field or similar.
- 4+ years of supervisory experience, leadership, and mentorship of fellow engineers.
- 3+ years of medical device manufacturing experience is highly desired.
- Advanced English.
- Demonstrate experience in ISO13485, FDA QSR, and all applicable regulations for MDSAP.
- ISO Risk management.
- Solid understanding and experience in the areas of Process Validation.
- Computer knowledge in Excel, Word, PowerPoint, Minitab, or others.
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.
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