The Quality Engineer will possess a thorough knowledge of the medical industry requirements and regulatory requirements. This individual will work with Cross Functional Management Teams to fully understand Customer part process requirements and to develop Quality Plans and Inspection Plans for Process Control.
- Process Improvement activities which include reviewing each step of individual processes and making them operator friendly, ergonomic, efficient, cost effective, capable and as error proof as possible.
- Implement a Visual Work Instruction System.
- Perform Capability Studies.
- Responsible for Process Validations, IQ, OQ and PQ testing and report writing.
- Responsible for Continual Improvement activities to enhance the quality system using Quality Improvement Tools, such as Design of Experiments, 5S, Kaizen, lean methods, mistake proofing, etc.
- Assist Quality manager in establishing, implementing and maintaining the Quality Management System.
- Support the Process Technicians to ensure that products and processes comply with the relevant requirements of the Quality Management System and Customer Requirements.
- Analyze Nonconformances, and implement corrective and preventive actions to respond to customer returns and/or complaints.
- Responsible for planning, organizing and managing the overall activities of receiving, in-process and out-going quality functions.
- Manage suppliers' performance and conduct audits as necessary.
- Root cause analysis and implementation of corrective action for process related concerns.
- Analyze non-conformance trends to evaluate effectiveness of corrective actions.
- Collect data for customer as requested by customer and/or Quality Manager as necessary.
- Assist with Measuring Equipment Calibrations.
- Conduct and support internal audits of the ISO 13485:2003 QMS; including completing corrective and preventive actions.
- Perform new hire Quality System training.
- Perform Final Inspection including AQL sampling and 100% Inspection of products, and associated paperwork.
- Desire to own decisions and take responsibility for outcomes.
- Willingness to continually improve personal and professional development.
Sthree US is acting as an Employment Business in relation to this vacancy.