Quality Systems Engineer: Medical Device Compliance & Audits

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

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.