Quality Systems Engineer – Medical Device QMS & Audits

Cretex Companies, Inc.; Brooklyn Park (MN); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus

Cretex University

Employee assistance program

Wellness program

Life insurance

Tuition assistance

Job summary

Cretex Medical in Minnesota seeks a Quality Systems Engineer to support and administer the QMS, drive CAPA, audits, training, and document control. You will help ensure compliance with ISO 13485, EU MDR, and FDA QSR and coordinate audit activities.

Candidates should have a Bachelor’s in Computer Science or related STEM and 5+ years in regulated quality environments, strong BI tooling awareness, and proficiency with MS Office.

Qualifications

• Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM field.
• 5+ years in 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.
• Ability to deliver short and long-term business results.
• MS 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.
• Travel up to 15%.

Responsibilities

• Identify, develop, and maintain QMS programs to promote quality awareness and ensure compliance to policies and procedures.
• Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up.
• Manage the internal audit program from selection and training to corrective actions.
• Assist in defining and improving quality system processes compliant with ISO 9001, ISO 13485, and FDA QSR.
• Active participation in internal audits related to regulatory standards.
• Technical content writer for new/revised procedure content within the quality system.
• Analyze data and identify improvement opportunities.
• Support CAPA activities and closing audit findings with corrective actions.
• Contribute to BI reporting and enterprise workflow design and administration.
• Ensure quality systems are maintained and compliant with ISO/medical device requirements.
• Travel up to 15%.

Skills

Quality systems knowledge

Regulatory standards knowledge

Analytical thinking

Clear communication

Attention to detail

Organization skills

Team collaboration

Travel readiness

Education

Bachelor’s Degree in Computer Science/Software Engineering

Tools

Business intelligence tools

Job description

Cretex Medical in Minnesota seeks a Quality Systems Engineer to support and administer the QMS, drive CAPA, audits, training, and document control. You will help ensure compliance with ISO 13485, EU MDR, and FDA QSR and coordinate audit activities.

Candidates should have a Bachelor’s in Computer Science or related STEM and 5+ years in regulated quality environments, strong BI tooling awareness, and proficiency with MS Office.