Quality Engineer II/III - Manufacturing QA Lead

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

Benefits offered by this job

401(k) retirement savings plan with a

Onsite health clinics

Discretionary holiday bonus program

Cretex University

Wellness program with incentives

Employee assistance program

Paid holidays and paid time off

Profit-sharing program

Tuition assistance programs

Job summary

Cretex Medical is seeking a Quality Engineer to provide quality assurance support for manufacturing. You will define and improve quality practices, develop inspection requirements, and support PFMEAs while guiding corrective actions.

The role requires a BS in Mechanical/Industrial Engineering and 3+ years (QE II) or 6+ years (QE III) in machining/manufacturing, with knowledge of quality systems, GD&T, DOE, Minitab, and strong communication. This is an onsite role with cross-functional teamwork.

Qualifications

• Bachelor's Degree in Mechanical, Industrial, or other Engineering Science.
• 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.
• Intermediate blueprint reading and GD&T.
• Ability to analyze data and ensure data integrity.
• Ability to operate a variety of inspection equipment.
• DOE and Capability Studies (statistical expertise).
• Minitab software.
• MS Office proficiency.

Responsibilities

• Provide quality assurance support for manufacturing.
• Define, implement, and improve quality-related practices and provide guidance on measurement methodologies.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create/maintain control and inspection plans.
• Analyze data and identify opportunities for improvement.
• Act as the quality interface for the production team addressing customer complaints using FA, CAPA, and trend analysis.
• Conduct audits; close out audit findings and determine corrective/preventive actions.
• Lead/participate in projects providing quality recommendations.
• Support validation activity of processes, equipment, and metrology.
• Create protocols and analyze data.
• Support inspectors to ensure inspection plans meet customer requirements.
• Comply with ISO and medical device requirements.
• Read/understand/follow work instructions and standard work.
• Partner with sales/marketing, customer service, engineering, quality, and finance.

Skills

Quality engineering

DOE

Data analysis

Blueprint reading

GD&T

Microsoft Office

Education

B.S. in Mechanical/Industrial Eng

Tools

Minitab

Job description

Cretex Medical is seeking a Quality Engineer to provide quality assurance support for manufacturing. You will define and improve quality practices, develop inspection requirements, and support PFMEAs while guiding corrective actions.

The role requires a BS in Mechanical/Industrial Engineering and 3+ years (QE II) or 6+ years (QE III) in machining/manufacturing, with knowledge of quality systems, GD&T, DOE, Minitab, and strong communication. This is an onsite role with cross-functional teamwork.