Quality Engineer II / III

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 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
• Lead and participate in intermediate company projects providing quality recommendations
• 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
• 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

Qualifications

• Bachelor's Degree in Mechanical, Industrial, or in other Engineering Science
• Quality Engineer II: 3+ years of experience in engineering in a machining or manufacturing setting
• Quality Engineer III: 6+ years of experience in engineering in a machining or manufacturing setting
• Intermediate knowledge of blueprint reading and GD&T
• Ability to analyze data and ensure data integrity
• Ability to operate a variety of inspection equipment
• Statistical expertise with DOE and capability studies
• Design software - Minitab
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail and organizational skills
• Ability to work in a fast-paced team environment, ability to prioritize and multitask

Preferred Knowledge, Skills And Abilities

• Continuing Education; including participation in local chapters, associations, and/or organizations