Quality Engineer II / III

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

Overview

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 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***

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

• Bachelors Degree in Mechanical, Industrial, or in other EngineeringScience
• 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 Capablity 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, ability to prioritize and multitask

Preferred Knowledge, Skills and Abilities

• Continuing Education; including 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:

Our 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 are available to all Cretex employees.

20+hours:

Cretex’s medical benefit package includes: 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 are available to employees working 20+ hours/week.

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 are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

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.