Quality Engineer II / III

Cretex Companies, Inc.; Dassel (MN); On-site; USD 75,000 - 136,200; Full time

Job summary

Cretex Medical is seeking a Quality Engineer II/III to provide quality assurance support for manufacturing. The role includes defining and improving quality practices, guiding measurement methods, and acting as a technical resource for the production team.

The position requires a mechanical/industrial engineering background with 3+ years for Level II or 6+ years for Level III, knowledge of GD&T, DOE, and quality systems.

Qualifications

• Bachelor's Degree in Mechanical, Industrial, or Engineering Science.
• Quality Engineer II: 3+ years of engineering experience in machining/manufacturing.
• Quality Engineer III: 6+ years of engineering experience in machining/manufacturing.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• GD&T reading ability and data analysis.
• Ability to operate inspection equipment.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; PFMEAs; corrective actions and ensure quality documents.
• Analyze data and identify improvement opportunities.
• Respond to customer complaints with failure analysis and CAPA (corrective and preventive actions).
• Lead audits and close out findings; recommend CAPA actions.
• Support validation of processes, equipment, and metrology.

Skills

Quality engineering

DOE

GD&T

Data analysis

Education

Bachelor's Degree in Mechanical, Industrial, or other Engineering Science

Tools

Outlook

Word

Excel

PowerPoint

Publisher

Job description

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 injection molding, laser processing, metal stamping and device assembly.

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.

Responsibilities

• 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 preventive actions and trend analysis.
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventive 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 relevant customer 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 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.

Skills

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

Pay Range

USD $75,000.00 - USD $136,200.00 /Yr.

Pay Range Details

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

Company Benefits

All Employees: 401(k) retirement savings plan with 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; employee death benefit; and employee sick and safe leave are available to all Cretex employees.

20+ hours: Medical benefit package including comprehensive medical insurance with 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: 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.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of 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.