Dirección
forma de trabajoQuality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
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 decision-making 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 non-conforming 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.
• Give guidance in statistical applications for validations and product evaluations
• 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
Bachelor degree in a Engineering Field or similar
4+ years of supervisory experience, leadership and mentorship of fellow engineers
3+ years medical device manufacturing experience is highly desired
Advanced English
Demonstrate experience in ISO13485, FDA QSR, and all applicable regulations for MDSAP
ISO 14971 - Risk management
Solid understanding and experience in the areas of Process Validation
Statistical Knowledge and applications
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
Candidates 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.
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