Quality Engineer II / III

Regulatory Jobs; Minnesota; On-site; USD 75,000 - 136,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus

Job summary

Cretex Medical seeks a Quality Engineer II/III to provide QA support for manufacturing, shaping quality practices, and guiding measurement methodologies. The role covers audits, PFMEAs, CAPA, data analysis, and interface with production teams to resolve issues and ensure regulatory compliance.

The candidate will work within a medical device-focused environment, collaborating with engineering, sales, and finance, and contributing to continuous improvement initiatives.

Qualifications

• Bachelor’s degree in mechanical/industrial engineering.
• Quality Engineer II: 3+ years in engineering in a machining/manufacturing setting.
• Quality Engineer III: 6+ years in engineering in a machining/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.
• DOE and Capability Studies skills; proficiency with Minitab.
• Strong communication and teamwork; detail orientation.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues; create and maintain control/inspection plans.
• Analyze data and identify improvement opportunities.
• Act as the quality interface for production; respond to customer complaints using FMEA, CAPA, and trend analysis.
• Conduct audits; close out findings; determine corrective and preventive actions.
• Lead and participate in projects; support validation of processes, equipment, and metrology.
• Create protocols and analyze data; ensure compliance with customer requirements and quality systems.

Skills

Quality systems knowledge

Regulatory knowledge

Data analysis

Communication skills

Attention to detail

Team collaboration

Education

Bachelor's Degree in Mechanical, Industrial, or in other EngineeringScience

Tools

Minitab

Microsoft Office

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 engineeringin 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 Cabability 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, abilityto prioritize and multitask

Preferred Knowledge, Skills and Abilities

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

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

"The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right."

"I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it."

"I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives."

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

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.