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Lead Quality Assurance Engineer
2 months ago
Quality Engineering is responsible for the formulation and execution of quality policies, procedures, and processes to guarantee that products and services adhere to regulatory standards and specifications.
Quality Assurance Role: This role is crucial in establishing a compliant and cost-efficient quality system that ensures the reliability, safety, and effectiveness of products and services. The position entails overseeing production activities, providing training to operational and quality control teams, and educating leadership on Quality policies and procedures, ensuring thorough quality reviews and documentation for all products and services.
Key Responsibilities:
- Ensure all tasks are executed in accordance with site and corporate Quality Management System (QMS) standards.
- Support the Quality Assurance System.
- Manage and support the internal audit program, including conducting quality audits and developing corrective/preventive actions.
- Facilitate training on the QA system.
- Compile and report metrics on a monthly, weekly, and quarterly basis during Management Reviews.
- Oversee databases for metric compilation and reporting.
- Create and present Quality Alerts to enhance manufacturing awareness and reinforce Quality requirements.
- Manage and support the Corrective and Preventive Action (CAPA) program, identifying root causes and preventive measures, and tracking CAPA actions and deadlines.
- Mentor CAPA champions and team members.
- Monitor and support supplier performance.
- Manage and support the Supplier Corrective Action Request (SCAR) program, initiate SCARs, and track corrective actions and deadlines. Conduct supplier audits and follow up as necessary.
- Investigate customer complaints within the area of responsibility, determining root causes and corrective/preventive actions.
- Oversee the nonconformance program, facilitating and approving root cause and corrective/preventive actions for nonconforming materials.
- Facilitate Material Review Board (MRB) activities and recommend dispositions for nonconforming products.
- Participate in quality improvement projects, collaborating with various departments including R&D, Marketing, Regulatory, and Clinical Affairs.
- Support cost-saving initiatives.
- Utilize statistical tools for analysis and data trending.
- Conduct process risk assessments and Failure Mode Effects Analysis (FMEA).
- Develop specifications and testing methods to meet customer and internal quality requirements, including drafting procedures as necessary.
- Review new and modified product designs and processes for quality compliance.
- Engage in applicable Quality System Standards and Regulations, including FDA, supplier, customer, and internal audits.
- Represent the Quality function in new product development and process transfer projects, providing quality engineering support.
- Lead and engage in production floor support and continuous improvement initiatives.
- Conduct QA Improvement Training (SPC, Five-Why, FDA, etc.).
- Maintain and evaluate sampling plans, updating product control plans, inspection, and testing standards as needed.
- Review and approve Document Change Requests (DCR).
- Monitor and maintain sterilization procedures and environmental monitoring as applicable, including bioburden and dose audits for sterile products.
- Receive general guidance and may receive detailed instructions on new projects.
- Perform additional job duties as assigned.
- Bachelor's degree in a related field or equivalent work experience preferred.
- 2+ years of experience in a related field preferred.
- Familiarity with FDA regulations regarding medical device manufacturing, Good Manufacturing Practices (GMPs), and process validations is advantageous.
- Able to apply working knowledge of concepts, principles, and technical capabilities to perform diverse tasks.
- Experience with projects of moderate scope and complexity.
- Ability to identify solutions to various technical challenges and take appropriate actions.
- Sound judgment within defined parameters.
- Proficient in PC skills and knowledgeable in MS Office preferred.
- Utilizes working knowledge of concepts, principles, and technical capabilities for varied tasks.
- Engages in projects of moderate scope and complexity.
- Identifies solutions to a range of technical issues and takes action to resolve them.
- Applies judgment within defined parameters.
- Receives general guidance and may receive detailed instructions on new projects.
- Work is reviewed for reasoning and accuracy.
Benefits: Cardinal Health provides a comprehensive array of benefits and programs to support health and well-being, including:
- Medical, dental, and vision coverage.
- Paid time off plan.
- Health savings account (HSA).
- 401k savings plan.
- Access to wages before payday with myFlexPay.
- Flexible spending accounts (FSAs).
- Short- and long-term disability coverage.
- Work-Life resources.
- Paid parental leave.
- Healthy lifestyle programs.
