Quality Engineer, QMS & Facilities - Audits & Compliance

Solventum; Brookings (SD); On-site; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Quality Engineer In QMS / Facilities to drive cross-functional validation activities and ensure compliance with quality systems. You will author IQ/OQ documents, participate in facility design, and support requalification efforts across production areas and labs.

The role partners with project managers and global teams to resolve design or damage issues while maintaining regulatory standards.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing with 5+ years in engineering, validations, quality, or technical role.
• Experience with troubleshooting, investigation, remedial action and non-conforming facility issues.
• Knowledge of ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR (21 CFR Part 11), and EU MDR preferred.

Responsibilities

• Lead cross-functional facilities validation/qualification activities.
• Write/perform IQ/OQ documentation for new or remodeled production areas and labs.
• Support facility design development and requalification activities.
• Review/approve facility and QMS documents and procedures for compliance.
• Lead internal audits and manage CAPAs.
• Coordinate with project managers, sterility, production and maintenance teams.

Skills

Quality Assurance

Regulatory knowledge

Investigation & analysis

Education

Bachelor's degree in science/engineering/manufacturing

Job description

Solventum is seeking a Quality Engineer In QMS / Facilities to drive cross-functional validation activities and ensure compliance with quality systems. You will author IQ/OQ documents, participate in facility design, and support requalification efforts across production areas and labs.

The role partners with project managers and global teams to resolve design or damage issues while maintaining regulatory standards.