Sup III-Engineering-General Engineering
Responsible for monitoring manufacturing process compliance to DMR requirements and quality system regulations. Supervises the Quality manufacturing operations crew and serves as mentor guider of all processes, product specifications and quality functions, providing technical support to assure process control. Drive process improvement and monitor product performance through identification, and support to key related projects and data trending through Monthly Indicators and Quality Trends / Management Review Meetings. Key player to manufacturing, validation and CAPA process, providing technical statistical support to assure process control. Assure product identification and quality status .process compliance.
- Knowledge of medical device regulations.
- Computer System, Window Microsoft– Office (Word, Excel, PowerPoint), 21 CFR Part 11, OSHA, GMP, General FDA Regulations, Good Documentation Practices, CAPA , Internal Audit, Training knowledge and application.
- Process and product validation and product design.
- Statistical techniques, process control tools and acceptance sampling knowledge.
- Written and verbal communication skills.
- Self-motivated and self-started.
- Able to work under minimum supervision.
- Able to handle multiple tasks at the same time.
- Willing to travel occasionally.
- Willing to work extra hours, Holidays (e.g. shutdowns, FDA, ISO or Third Party Audits).