Quality Systems Engineer — Impactful QMS & Compliance

Solventum-; St. Louis (MO); On-site; USD 90,000 - 110,000; Full time

Job summary

Solventum, a new healthcare company, is seeking a Quality Systems Engineer to join the Medical Surgical Division in Maryland Heights, Missouri. This onsite role focuses on managing the QMS, ensuring regulatory compliance, and supporting audits to improve patient outcomes.

You will lead document control efforts, drive process improvements, and work with cross-functional teams to maintain accuracy and readiness for customer and regulator inspections.

Qualifications

• Bachelor degree and at least 5 years in Quality Management Systems (QMS) or equivalent regulated environment.
• ISO 13485, ISO 9001 experience preferred.
• Technical writing and CAPA experience required.
• ISO 13485 Lead Auditor Certification is a plus.

Responsibilities

• Manage various elements of the QMS to ensure compliance and continuous improvement.
• Ensure compliance to relevant regulations and standards.
• Create and support QMS document control and document change processes.
• Host customer audits and regulator inspections for the site.
• Lead internal audits and drive corrective actions.
• Support reporting and system use/training as needed.
• Process document changes in an efficient and timely manner.
• Ensure accuracy and completeness of documents in the controlled system.
• Ensure document controls in place for technical accuracy and review.
• Follow global and business processes and procedures.
• Interpret regulations and represent the customer to foster a quality culture.

Skills

QMS experience

Technical writing

CAPA writing & coaching

Regulatory interpretation

Education

Bachelor of Science degree

High School Diploma/GED

Job description

Solventum, a new healthcare company, is seeking a Quality Systems Engineer to join the Medical Surgical Division in Maryland Heights, Missouri. This onsite role focuses on managing the QMS, ensuring regulatory compliance, and supporting audits to improve patient outcomes.

You will lead document control efforts, drive process improvements, and work with cross-functional teams to maintain accuracy and readiness for customer and regulator inspections.