Quality Systems Engineer – Medical Device QMS & Audits

Regulatory Jobs; Brooklyn Park (MN); Sur place; USD 75 000 - 113 000; Plein temps

Résumé du poste

Cretex Medical is seeking a Quality Systems Engineer to support and administer enterprise level QMS processes, including CAPA, audits, training, and standards library. You will ensure ISO 9001/13485 and FDA QSR compliance, develop and revise procedures, analyze data, and drive continuous quality improvement across manufacturing operations.

The role requires experience in quality management systems within regulated environments, strong communication skills, and the ability to travel up to 15%.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Programming, or related STEM field.
• 5+ years of experience 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.
• Clear and effective verbal and written communication skills.

Responsabilités

• Identify, develop, and maintain QMS programs to promote quality awareness and ensure compliance to company policies and procedures.
• Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up activities.
• Manage the internal audit program from selection and training of the internal audit group through effective corrective actions.
• Assist in defining and improving quality system business processes compliant to ISO 9001, ISO 13485, and FDA QSR.
• Participate in required company meetings and maintain an organized work area (5S).
• Implement, monitor, and lead CAPAs from audits and investigations.
• Contribute to BI reporting and dashboard design and validation.

Formation

Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program

Outils

Microsoft Office

Business intelligence software tools

Description du poste

Cretex Medical is seeking a Quality Systems Engineer to support and administer enterprise level QMS processes, including CAPA, audits, training, and standards library. You will ensure ISO 9001/13485 and FDA QSR compliance, develop and revise procedures, analyze data, and drive continuous quality improvement across manufacturing operations.

The role requires experience in quality management systems within regulated environments, strong communication skills, and the ability to travel up to 15%.