Facilities Quality Engineer — QMS & Compliance Lead

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

Job summary

Solventum is seeking a QMS/Facilities Quality Engineer to lead validations and QA activities at the Brookings, SD site. You will write IQ/OQ documentation, support facility design, and manage CAPAs with cross-functional teams.

The role requires a Bachelor's in science/engineering and 7+ years in related fields, with strong regulatory knowledge and auditing experience. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing with 7+ years in related roles.
• Experience in engineering, validations, quality, or other technical roles.
• Familiarity with ISO 13485, ISO 9001, MDSAP, FDA QSR, EU MDR regulations.

Responsibilities

• Lead cross-functional facilities validation/qualification activities with IQ/OQ documentation.
• Participate in facility design development and requalification processes.
• Oversee facility maintenance, contamination control, and audit readiness.
• Develop, review, and approve QMS documents and procedures to meet regulations.
• Coordinate with project managers, sterility, production, and maintenance teams.
• Lead internal audits and manage CAPAs; host external audits when needed.

Skills

Cross-functional collaboration

Facility validations

IQ/OQ documentation

Regulatory standards knowledge

Auditing

Troubleshooting

Education

Bachelor's degree in science/engineering/manufacturing

Tools

Test equipment knowledge

Metrology

Job description

Solventum is seeking a QMS/Facilities Quality Engineer to lead validations and QA activities at the Brookings, SD site. You will write IQ/OQ documentation, support facility design, and manage CAPAs with cross-functional teams.

The role requires a Bachelor's in science/engineering and 7+ years in related fields, with strong regulatory knowledge and auditing experience. Travel up to 10% may be required.