Quality Engineer – QMS & Facilities Leader

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

Benefits offered by this job

Medical, Dental & Vision

Retirement benefits

Job summary

Solventum is seeking a Quality Engineer for QMS/Facilities at the Brookings, SD site to drive validations and document control. You will coordinate IQ/OQ activities, support facility requalification, and ensure compliance with regulatory standards.

As the QMS SME, you will lead internal audits, manage CAPAs, and collaborate with project teams to address facility issues and improve processes in a complex manufacturing environment.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing.
• OR High School Diploma/GED with 12+ years in science, engineering, or manufacturing.
• 5+ years in engineering, validations, quality or related technical role.
• Knowledge of medical device regulations (ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR, EU MDR).

Responsibilities

• Lead cross-functional facilities validations and IQ/OQ documentation.
• Support requalification of facility areas and HEPA filters.
• Manage CAPAs and audit reports; host external audits when needed.
• Act as QMS SME for regulatory questions and pest management programs.

Education

Bachelor's degree in science/engineering/manufacturing

High School Diploma/GED with 12+ years experience

Job description

Solventum is seeking a Quality Engineer for QMS/Facilities at the Brookings, SD site to drive validations and document control. You will coordinate IQ/OQ activities, support facility requalification, and ensure compliance with regulatory standards.

As the QMS SME, you will lead internal audits, manage CAPAs, and collaborate with project teams to address facility issues and improve processes in a complex manufacturing environment.