Quality Engineer
Quality Engineer
Hitemco Medical Applications, Inc.
Old Bethpage, New York
Company Profile
Himed is a biomaterial coating characterization company that provides biocompatible coating and texturing solutions along with raw biomaterials to clients in the medical, dental, laboratory, and research industries. With its all-in-one research and production facility located in Old Bethpage, NY, Himed has been serving as a vital partner to its clients since 1991, providing healing technologies that have greatly enhanced outcomes for patients around the world. The company takes pride in its reputation for quality, consistency, and collaboration.
Position Overview
The Quality Engineer will be responsible for developing systems, procedures, and controls utilizing expert skills in process and project management coupled with statistical techniques. Reporting to the Quality Assurance Manager, the successful hire will lead cross functional teams in the implementation of continuous improvement activities, analyze production processes and utilize problem solving methodology to identify root causes and develop creative, appropriate solutions. The Quality Engineer shall be a proficient user of six sigma methodologies to reduce manufacturing variability and statistical analysis methods for process control as well as leading initiatives that reduce waste and non-value added activity utilizing Lean principles.
Position Responsibilities
- Responsible for Quality System Maintenance.
- Root cause analysis and implementation of corrective action for process related concerns.
- Calibration of machinery.
- Assist Quality Assurance Manager in establishing, implementing and maintaining the quality management system.
- Responsible for continual improvement activities to enhance the quality system, such as 5S, lean methods, etc.
- Assists in managing maintenance program.
- Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
- Support Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
- Support Quality Team with Quality Release Testing.
- 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.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Preparation of QA reports, including customer validations (i.e., IQ, OQ, and PQ).
- Assist Engineering team with equipment validation and programming.
- Analyze data trends regarding production.
Qualification and Requirements
- Familiarity with ISO and FDA regulations and guidelines.
- Current knowledge of and experience with quality improvement techniques, including SPC, and structured problem solving techniques.
- Demonstration of team leadership and to be a driver of change agent methodologies and various communication tools.
- Excellent problem solving skills, including previous experience leading problem solving groups.
- Excellent understanding of data analysis tools including Excel, MS Access and Minitab.
- Excellent communication skills, both oral and written, are fundamental.
- Supplier validation and qualification experience.
- Individual must be able to work independently and will interface with internal and customer counterparts at all levels.
- Experience in the healthcare industry is a plus
- Bachelor's degree in Engineering or related field
- Physical demands: Strong visual acuity