Skaneateles Falls, NY4 days ago
Education Requirements:- Bachelor's degree in EngineeringRequired Skills for the Engineer - Quality Complaint Investigation:- 1-3 years of Medical Device experience- Investigational research skills- Experience with any statistical software packages - Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements- Knowledge and working application of reading and understanding blueprints and technical drawings- Demonstrated strong analytical problem solving - Root Cause Investigations- Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools)- Computer competency in Word, Excel, Power Point, Minitab, Access and databases- Ability to multi-task and methodically manage projectsPreferred Skills:- Medical Device knowledge of 21CFR820 preferred- Minitab statistical package- Experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods- CMDASEngineer - Quality Complaint Investigation Overview:This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Develop strategies and plans to close the gaps in an efficient and technical manner- Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions- Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation- Support CAPA and maintenance activities for existing product lines- Recommend and/or support projects for improvements to the quality system as approved by management **Only those lawfully authorized to work in the designated country associated with the position will be considered.**