Automation Director - Cordx : Job Details
Automation Director
CordxJob Location : all cities,GA, USA
Posted on :
2024-12-01T00:14:12Z
Job Description :
About Us
CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drug abuse, biomarkers and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Summary:
In the MD industry, an Automation Director is responsible for implementing automation technologies and ensuring all systems and processes meet MDSAP and other global compliance standards. Success in this role hinges on integrating ERP, OA, and automation equipment with regulatory standards, optimizing operational efficiency and compliance.
1. Responsibilities- Develop and implement an automation strategy that aligns with MDSAP requirements across production and quality control automation processes.
- Identify and adopt automation technologies that meet industry regulations, such as ISO 13485 and FDA 21 CFR 820, ensuring compliance with global quality standards.
- Oversee the selection, implementation, and integration of ERP (e.g., SAP, Oracle) and OA systems to streamline business and quality processes, ensuring seamless interaction with automation systems.
- Lead ongoing improvements in production and business processes, using automation technology and analytics to maximize efficiency, quality, and cost-effectiveness.
- Implement data management and governance strategies to ensure data accuracy in automation systems, providing real-time reporting to support MDSAP-compliant quality requirements.
- Work closely with quality, IT, production, and compliance teams to ensure automation systems and processes align with the quality management system (QMS) and global audit requirements.
- Conduct regular system performance, compliance, and risk assessments to support MDSAP audits and ensure alignment with regional compliance standards.
- Promote internal training on automation skills, ensuring staff are proficient with MDSAP standards and company automation systems.
- Identify automation needs in business and production areas, evaluating various automation solutions for compliance with MDSAP standards.
- Ensure ERP and OA systems are configured to meet quality and regulatory requirements and are fully integrated with production automation and data analytics tools.
- Conduct tests and validations for automation processes to ensure compliance with ISO 13485 and FDA CFR 820, with a focus on quality control and data traceability.
- Monitor system performance in real time, generate MDSAP-compliant reports, and regularly evaluate process efficiency and quality for data-driven improvements.
- Regularly perform internal audits to identify compliance risks, ensuring the organization is always prepared for MDSAP and other external audits.
- Measure the improvement in production efficiency post-automation, aiming for reduced production time and costs.
- Track the compliance rate of production and quality processes, aiming for 100% adherence to MDSAP, ISO 13485, and FDA standards.
- Monitor automation equipment uptime and failure frequency to ensure continuous production and equipment reliability.
- Measure the company's pass rate in MDSAP audits, ensuring compliance with multi-market regulations.
- Assess the accuracy and timeliness of reports generated by the automation system, supporting data-driven decision-making and real-time monitoring.
- Ensure the team completes regular training on automation and compliance, enhancing operational competency and supporting continuous improvement.
- Expertise in integrating and configuring ERP (e.g., SAP, Oracle), OA, PLC (Programmable Logic Controller), and other automation systems, with a strong grasp of device connectivity and system optimization.
- Proficiency in MDSAP, ISO 13485, FDA CFR 820, and other regulatory standards to ensure automation systems and processes align with global MD quality and compliance requirements.
- Skilled in data analysis tools (e.g., Power BI, Tableau) to generate automation reports and drive process improvements and decision support.
- Project management expertise (e.g., PMP certification) to lead cross-functional teams and implement automation and process optimization projects effectively.
- Strong communication and team management abilities to train and lead teams, foster an automation culture, and enhance cross-departmental collaboration.
- Competent in risk assessment to identify and mitigate compliance risks related to automation, supporting MDSAP audit readiness and management.
- BS/MS in a scientific (biochemistry, molecular biology, etc.), engineering (chemical, mechanical, etc.), or computational (computer science, etc.) discipline with 8+ years relevant experience.
Benefits:
- Medical Insurance
- Retirement Plan
- Paid Time-Off
- Opportunities for professional development and career advancement
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