Quality Engineer
Spectrum Plastics Group
Summary
The Quality Engineer is responsible for risk assessment of activities stated within the Quality Management System. This position must execute and coordinate root cause analysis investigations with other areas within the organization. Where applicable, the QE will also be responsible for support activities such as calibrations and clean room controls.
Job description
- Perform risk analysis of processes within the organization.
- Coordinate calibration activities as defined by standard operating procedures.
- Develop standard operating procedures that support QMS.
- Coordinate Management Review meetings.
- Coordinate and execute activities related to clean room controls where applicable.
- Responsible for coordination of teams aimed at responding to customer complaints and perform root cause analysis using appropriate tools.
- Responsible for providing the final response to customers.
- Participate in product validations whenever required.
- Evaluate new customer specifications whenever required.
- Provide support to Quality Systems Engineer.
- Perform Measurement System Analysis when required.
- Update Control Plans.
- Coordinate Continuous Improvement Efforts.
- Perform internal audits when required.
- Perform any tasks requested by immediate supervisor.
Requirements
- Engineering Degree in Mechanical/Industrial/Chemical Engineering or equivalent experience
- Certified Quality Engineer (ASQ) desired
- Six Sigma Black Belt Training desired
- Proficient in the use of Microsoft Office Suite
- Knowledge of statistical tools such as Gage RR, Hypothesis Testing, Design of Experiments
- Knowledge of Minitab statistical software
Company overview
Spectrum Plastics Group is a leading global manufacturer of specialty medical device components and assemblies, serving the healthcare industry with precision-engineered plastic solutions. The company specializes in the design, development, and manufacturing of critical components for medical devices across various therapeutic areas including cardiovascular, surgical, diagnostic, and drug delivery applications. With expertise in advanced polymer processing technologies, Spectrum provides custom solutions that meet stringent regulatory requirements and quality standards essential for medical applications. Their comprehensive capabilities encompass extrusion, injection molding, balloon catheter manufacturing, and complex assembly operations, supporting medical device OEMs in bringing innovative healthcare solutions to market. The company's focus on quality, reliability, and technical innovation has established it as a trusted partner in the medical device supply chain, contributing to improved patient outcomes through precision-engineered components that meet the demanding requirements of modern medical technology.