Quality Engineer II / III

Overview

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.

Responsibilities

• Quality engineering support for manufacturing and project management
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document 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
• Knowledge of quality systems, regulatory requirements, and industry standards
• Statistical expertise with DOE and capability studies
• Design software - Minitab
• Ability to analyze data and ensure data integrity
• Ability to operate a variety of inspection equipment
• Ability to consistently achieve short and long-term business results
• 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

Skills

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

Company Benefits

• All Employees: 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave
• 20+ hours: Comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program
• 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs