Quality Engineer II / III

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 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.

Quality Engineer 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.

• Position is open to Quality Engineer level II or III based on experience***
• 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
• Bachelor's Degree in Mechanical, Industrial, or 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
• Knowledge of quality systems, regulatory requirements, and industry standards
• 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
• 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, prioritize and multitask

Preferred Knowledge, Skills And Abilities

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

USD $75,000.00 - USD $136,200.00 /Yr. This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market‑based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

Quality Engineer II: $75,000 - $112,600
Quality Engineer III: $90,800 - $136,200
All Employees: 401(k) retirement savings plan with a company match contribution; onsite health clinics; discretionary holiday bonus program; Cretex University; 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost; wellness program with incentives; employee death benefit; and employee sick and safe leave are available to all Cretex employees.

20+ hours/week: medical benefit package includes comprehensive medical insurance with access to virtual providers; dental insurance; vision insurance; pre‑tax health savings account; healthcare and dependent care pre‑tax reimbursement accounts; paid holidays; paid time off; and discretionary profit‑sharing program.

30+ hours/week: 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.

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.