Quality Engineer III- Molding

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position Summary

The Quality Engineer III will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

• Quality engineering support for manufacturing and project management
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents such as control plans and inspection plans
• Analyze data and identify improvement opportunities
• Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
• Coach and mentor Quality Engineer levels, I and II
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge)
• Lead and participate in large company projects providing quality recommendations
• Support Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer’s product requirements
• Support validation activity of processes, equipment, and metrology
• Create protocols and analyze data
• Support the Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer’s product requirements
• Ensure business systems are implemented, maintained, and functioning properly
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Partner with other business segments sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve
• Maintain an organized work area (5S)
• Participate in required company meetings
• Complete all other work duties as assigned

Qualifications

• Ability to work in a manufacturing environment
• Bachelor’s Degree in Mechanical, Industrial, or in another Engineering Science
• 6 years of experience in engineering in a machining or manufacturing setting
• Knowledge of quality systems, regulatory requirements, and industry standards
• Advanced knowledge of blueprint reading and GD&T
• Statistical expertise with DOE and Capability Studies
• Design software- Minitab
• Process management
• Ability to operate and train to a variety of inspection equipment

Desirable Criteria & Qualifications

• Experience in injection molding
• Experience in the med device industry