The main purpose of thisrole is to perform semi-standardized or semi-prescribed tasks that require judgment and problem-solving skills. Responsible for updating and reviewing procedures or standard equipment.
The position is also responsible for monitoring of compliance with cleanroom requirements during production and ensures product quality for dimensional, electrical and visual workmanship standards according to customer requirements.
ROLES AND RESPONSIBILITIES
Closely monitors daily, weekly and monthly quality indicators and metrics. Identifies and evaluates procedures to ensure the manufacturing aligned with our quality standards.Validates product specifications using measurement tools and techniques.Conducts studies to understand the capability of process and/or measurement systems.Provides technical support as required by the quality team and other areas.Performs the final review of the Manufacturing Device History Record (DHR) at the end of the manufacturing process and product launch.Makes decisions about how to handle product issues with the operator accordingly and issues related to whether the product is acceptable or not.Prepares technical reports, standards and rejection records, and other required quality documentation.Sets up and run experiments and/or test devices with steering.Provides inputs in the evaluation of equipment and processes.Demonstrates safe work habits, maintains a clean and safe work area.Requirements
- Technical degree and or advanced university studies in the areas of engineering, quality, Life Sciences is required.
- At least 3 years of experience in the medical industry or highly regulated industry is required.
- Proficient in Excel, Word and MS Office/PC applications.
- Intermediate or advanced verbal and written English language skills.
- Knowledge in Metrology.
- Desirable knowledge in equipment calibration.
Benefits
Market competitive package