Automation Co-Director
CorDx Atlanta
- Automation Strategy and Compliance Implementation
- 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.
- ERP and OA Systems Integration
- 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.
- Process Optimization and Continuous Improvement
- Lead ongoing improvements in production and business processes, using automation technology and analytics to maximize efficiency, quality, and cost-effectiveness.
- Data Governance and Quality Control
- Implement data management and governance strategies to ensure data accuracy in automation systems, providing real-time reporting to support MDSAP-compliant quality requirements.
- Cross-Department Collaboration
- 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.
- Compliance Monitoring and Internal Audits
- Conduct regular system performance, compliance, and risk assessments to support MDSAP audits and ensure alignment with regional compliance standards.
- Employee Training and Culture Promotion
- Promote internal training on automation skills, ensuring staff are proficient with MDSAP standards and company automation systems.
- Fluent in Chinese and English
- Technical and Systems Integration Skills
- 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.
- Quality Management and Regulatory Compliance Knowledge
- 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.
- Data Analysis and Reporting
- Skilled in data analysis tools (e.g., Power BI, Tableau) to generate automation reports and drive process improvements and decision support.
- Project Management and Continuous Improvement
- Project management expertise (e.g., PMP certification) to lead cross-functional teams and implement automation and process optimization projects effectively.
- Team Leadership and Cross-Department Collaboration
- Strong communication and team management abilities to train and lead teams, foster an automation culture, and enhance cross-departmental collaboration.
- Risk Assessment and Compliance Monitoring
- Competent in risk assessment to identify and mitigate compliance risks related to automation, supporting MDSAP audit readiness and management.
- Health Care Plan (Medical)
- Retirement Plan
- Paid Time Off
- Training & Development
- Company Sponsored Meals
- Individual and Team Bonding Spending
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