Quality Engineer II/III — Device Quality & Improvement

Cretex Medical Component and Device Technologies; West View Terrace (MN); On-site; USD 75,000 - 136,200; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Holiday bonus program

Cretex University

Employee assistance program

Job summary

Cretex Medical is seeking a Quality Engineer II or III to provide quality assurance support for manufacturing. The role will define, implement, and improve quality practices and provide technical guidance across the organization.

The candidate will support audits, CAPA, DOE, and data-driven improvements, working with cross-functional teams to ensure product quality and regulatory compliance. This position is open to multiple experience levels based on qualifications.

Qualifications

• Bachelor's degree in Mechanical or Industrial Engineering
• Quality Engineer II: 3+ years in machining/manufacturing
• Quality Engineer III: 6+ years in machining/manufacturing
• Knowledge of quality systems, regulatory requirements, and industry standards
• Blue print reading and GD&T knowledge
• Ability to analyze data and ensure data integrity
• Operate various inspection equipment
• DOE and Capability Studies statistics
• Minitab software
• MS Office proficiency

Responsibilities

• Quality engineering support for manufacturing and project management
• Develop inspection requirements; facilitate PFMEAs; resolve material issues and maintain quality documents
• Analyze data and identify improvement opportunities
• Act as the quality interface for production teams addressing customer complaints using failure analysis and CAPA
• Conduct audits and close out findings with corrective actions
• Lead or participate in projects providing quality recommendations
• Support validation of processes, equipment, and metrology
• Create protocols and analyze data
• Support Quality Inspectors to ensure inspection plans meet customer requirements
• Support and comply with Quality System, ISO and medical device requirements
• Read and follow work instructions and standard work
• Partner with sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and core markets served

Skills

Quality engineering

Data analysis

Blueprint reading

GD&T

DOE

Minitab

Microsoft Office

Regulatory knowledge

Education

Bachelor's degree in Mechanical/Industrial Engineering

Tools

Inspection equipment

Job description

Cretex Medical is seeking a Quality Engineer II or III to provide quality assurance support for manufacturing. The role will define, implement, and improve quality practices and provide technical guidance across the organization.

The candidate will support audits, CAPA, DOE, and data-driven improvements, working with cross-functional teams to ensure product quality and regulatory compliance. This position is open to multiple experience levels based on qualifications.