Automation Co-Director

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. Compliance Monitoring and Internal Audits

• Conduct regular system performance, compliance, and risk assessments to support MDSAP audits and ensure alignment with regional compliance standards.

1. Employee Training and Culture Promotion

• Promote internal training on automation skills, ensuring staff are proficient with MDSAP standards and company automation systems.

Requirements

1. Fluent in Chinese and English
2. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. Risk Assessment and Compliance Monitoring

• Competent in risk assessment to identify and mitigate compliance risks related to automation, supporting MDSAP audit readiness and management.

Benefits

• Health Care Plan (Medical)
• Retirement Plan
• Paid Time Off
• Training & Development
• Company Sponsored Meals
• Individual and Team Bonding Spending