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Quality Assurance Supervisor
hace 2 meses
We are seeking a highly skilled Quality Assurance Supervisor to join our team at Cardinal Health. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our medical device manufacturing processes.
Key Responsibilities- Act as a regulatory expert for functional teams, executing change management and validations activities for products, processes, materials, and software.
- Support and guide QA Engineering activities related to projects impacting the facility, product, and manufacturing operation.
- Lead the Risk Management Process for the manufacturing site and products under responsibility, ensuring decision-making based on risk.
- Support and guide the team in product and process investigations arising from manufacturing, processes, facilities, suppliers, materials, complaints, and nonconformities.
- Directly responsible for handling non-conforming product and ensuring adequate disposal and retention based on applicable procedures and regulations.
- Support and direct transfer projects and new products to ensure compliance and effectiveness.
- 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 comply with the quality system, corporate policies, regulations, and 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 distributed product analysis.
- Develop and manage quality engineers to ensure compliance with activities, knowledge, and growth.
- Lead continuous improvement projects focused on product quality, patient safety, efficiency, and cost.
- 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 language skills.
- Demonstrate experience in ISO13485, FDA QSR, and applicable regulations for MDSAP.
- ISO Risk management.
- Solid understanding and experience in Process Validation.
- Computer knowledge in Excel, Word, PowerPoint, Minitab, or others.
Cardinal Health is 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.
