About this opportunity
Cretex Medical Component and Device Technologies lists this Quality Systems Engineer opportunity in minneapolis, Minnesota. Review the employer’s description below for duties, qualifications and application requirements.
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 the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at
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
Position Summary
The Quality Systems Engineer will be responsible for providing core quality business process support & administration enabling enterprise level compliance. This position is responsible for ensuring a compliant Quality Management system including analysis, development, and revision of QMS processes, performing monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. This position will be tasked with direct facilitation and administration of core business processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer Audit, Regulatory Audit, and QMS/Regulatory Training.
Identify, develop, and maintain relevant QMS programs to promote quality awareness and ensure compliance to company policies and procedures includingEngineering & Document Changes
Corrective & Preventive Action
Standards Library Administration
Internal Audit Management
Customer Audit Management
Regulatory Audit management
Facilitating QMS & Regulatory Training Management
Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow‑up activities
Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions
Assist in the definition of and continuous improvement of quality system business processes compliant to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR.
Active participation in internal audits associated to ISO 9001, ISO 13485, and/or FDA QSR regulatory standards.
Technical content writer of new and/or revising procedure/policy content within scope of the quality system.
Analyze data and identify improvement opportunities.
Support audit activities such as closing out audit findings, creating audit finding reports and collaborating on determining the proper corrective and preventative actions.
Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third‑party, and internal audits.
Technical contributor to initiatives associated toBusiness intelligence reporting and dashboard design & validation.
Enterprise business workflow design & administration
Quality system business process automation through software based systems.
Ensure business systems are supported, maintained, and functioning to defined requirements.
Support and comply with the company Quality System, ISO, and medical device requirements
Read, understand, and follow work instructions and standard work
Participate in required company meetings
Maintain an organized work area (5S)
Participate in the Operational Excellence Program
Complete all other work duties as assigned
Ability to work in a manufacturing environment
Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program.
5+ years of experience working with quality management systems in regulated environment (ISO 13485, EUMDR, FDA)
Knowledge of quality systems, regulatory requirements, and industry standards
Academic experience with business intelligence software tools
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
Organizational skills
Ability to work in a fast‑paced team environment
Ability to prioritize and multitask
Ability to travel up to 15%
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.
USD $75,000.00 - USD $112,600.00 /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 .
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
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Worksite address
minneapolis, MN, 55400, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.