Description
Key job duties/responsibilities of Quality engineer:- Responsible for Quality System Maintenance.
- Root cause analysis and implementation of corrective action for process related concerns.
- Assist QA/RA director in establishing, implementing and maintaining the quality management system.
- Responsible for continual improvement activities to enhance the quality system, such as 5 S, Kaizen lean methods, etc.
- Develop training to build quality awareness.
- Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
- Support Engineering/ Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
- Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Assist QA/RA to create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
- Continuously improving QA receiving inspection process and procedures.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Manage suppliers' performance and conduct audits.
- Trend data and prepare QA reports.
Requirements:
- BS degree in Engineering or Science related field is required, plus directly related experience, or a combination of education and experience required to perform at this level
- 5 years experience in medical field with Quality Assurance and ISO strongly desired
- Excellent project management skills, uses deep functional expertise to help internal/external customers meet their priority needs
- ISO 13485 certification is preferred.
- Knowledge of manufacturing processes and relevant statistical techniques
- Understanding of continuous improvement methodologies
- Ability to work independently with minimal supervision and execute both short and long term multiple projects within desired time frames
To find out more about Real Staffing please visit www.realstaffing.com