Quality Systems Engineer

Cretex Medical Component and Device Technologies; Minneapolis (MN); On-site; USD 75,000 - 113,000; Full time

Job summary

Cretex Medical is seeking a Quality Systems Engineer to support and administer the QMS across ISO 9001, ISO 13485, and FDA QSR requirements. You will lead internal and supplier audits, develop corrective actions, and drive continuous improvement through data analysis and BI-driven insights.

Responsibilities include documenting changes, training, and ensuring regulatory compliance. A Bachelor’s degree in a STEM field and 5+ years’ experience in regulated environments are required.

Qualifications

• Bachelor’s degree in CS/Software Eng or related STEM.
• 5+ years of experience with quality management systems in regulated environments (ISO 13485, EU MDR, FDA).
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Academic experience with business intelligence software tools.
• Strong verbal and written communication skills; attention to detail and organization.
• Ability to travel up to 15%.

Responsibilities

• Identify, develop, and maintain QMS programs to promote compliance.
• Lead internal, external and supplier audits; prepare reports and follow-up actions.
• Manage the internal audit program from selection to corrective actions.
• Support ISO 9001, ISO 13485, FDA QSR compliance and continuous improvement.
• Write and revise procedures and policies within the quality system.
• Analyze data to identify improvement opportunities and action plans.
• Implement CAPAs from audits and drive effective corrective actions.
• Assist initiatives in BI reporting, enterprise workflow, and QA automation.

Skills

Quality management

Regulatory compliance

Audits

Documentation

Data analysis

BI tools

Communication

Attention to detail

Teamwork

Travel 15%

Education

Bachelor’s degree in CS/Software Eng or related STEM

Tools

BI software

MS Office

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 www.cretexmedical.com.

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.

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 including
  • Engineering & 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 to
  • Business 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 www.dhs.gov/E-Verify.