Malone
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Job ID: 714718
Company Overview:
Our client, a plastic injection molder and tool builder, is an “entrepreneurial” manufacturer whose customers are leaders in the medical device, defense, homeland security and technology industries including Fortune 500 OEMs. Business has started to grow dramatically. And we are currently looking for an experienced Quality Engineer to join our team.
Our client is more than just a manufacturer; we partner with Fortune 500 OEMs in the medical device, defense, homeland security, and technology sectors, constantly pushing the boundaries of product development and manufacturing excellence.
Essential Duties and Responsibilities:
- Develop, implement, and maintain quality control processes to ensure compliance with industry standards, customer requirements, and regulatory guidelines.
- Perform statistical process control (SPC) analysis and recommend process improvements to enhance product quality.
- Organization of metrology lab to ensure accurate project commitments and equipment scheduling.
- Interface with external customers to address their needs as related to product quality concerns and data requirements.
- Research validity of customer requests to return product.
- Lead root cause/corrective action/effectiveness verification activities.
- Develop, test, and implement effective and efficient product measurement methods / related quality records.
- Analyze product quality performance using statistical tools and methods.
- Assist with tool qualification and part approval activities, including first article inspection, capability studies, data analysis, PPAP documentation and formal report preparation and submittal.
- Assist with process validation activities, including product measurement and data analysis.
- Lead Gage Repeatability and Reproducibility study, shrink study, and PFMEA activities.
- Lead/conduct quality management system internal audits.
- Assist with development and implementation of ISO QMS documentation and required records.
- Attend and provide input during print review meetings & fixture design meetings.
- Lead/conduct quality management system internal audits.
- Provide training and guidance to production teams on quality standards, inspection techniques, and best practices.
- Work closely with production, engineering, and supply chain teams to address quality concerns and implement process enhancements.
- Coordinate special projects as required.
- Other duties as assigned by the Quality Supervisor.
Job Qualifications:
- Bachelor’s degree in Engineering, Quality, or a related field Preferred – Not required with relevant experience.
- 2+ years of experience in quality engineering within a plastics manufacturing environment.
- Familiarity with injection molding, extrusion, or other plastics manufacturing processes.
- Medical Molding and ISO-13485 knowledge strongly desired.
- Full Quality skillset including IQ/OQ/PQ, GD&T, Root-Cause, Corrective Actions (CAPA), etc.
- Excellent problem-solving skills and attention to detail.
- Strong communication skills with the ability to work cross-functionally.
Malone Workforce Solutions is an equal opportunity employer.
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