Quality Engineer, QMS & Facilities — Lead Audits

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

Job summary

Solventum in Brookings, SD, is seeking a QMS / Facilities Quality Engineer to lead cross-functional validation activities, write IQ/OQ/DQ docs, and support facility qualification and remediation efforts.

You will partner with global sterility, production, and maintenance teams to tackle facility design and contamination issues, lead internal audits, and manage CAPAs within the QMS framework. A strong regulatory background is required.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing discipline is required.
• Five or more years of experience in engineering, validations, quality, or a technical role.
• Knowledge of ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR, and EU MDR regulations.

Responsibilities

• Lead cross functional facilities validations / qualification activities (IQ/OQ).
• Support facility requalification and contamination control efforts.
• Draft, review and approve Facility and QMS documents/procedures.
• Coordinate with project managers, global sterility, production and maintenance teams.
• Lead internal audits and audit teams; manage CAPAs.
• Act as QMS SME for plant questions and regulatory standards.

Skills

Troubleshooting

Investigation

Remedial Action

Non-conforming issue analysis

Regulatory knowledge (ISO 13485 ISO 90

Education

Bachelor's degree in science, engineering, or manufacturing discipline

Job description

Solventum in Brookings, SD, is seeking a QMS / Facilities Quality Engineer to lead cross-functional validation activities, write IQ/OQ/DQ docs, and support facility qualification and remediation efforts.

You will partner with global sterility, production, and maintenance teams to tackle facility design and contamination issues, lead internal audits, and manage CAPAs within the QMS framework. A strong regulatory background is required.