Quality Engineer - QMS & Facilities Compliance Lead

USA SOLVENTUM US LLC; Brookings (SD); On-site; USD 124,000 - 171,000; Full time

Job summary

Solventum, Brookings, SD, seeks a Quality Engineer in QMS/Facilities to lead cross-functional validations, support requalification, and maintain QMS documentation. You will collaborate with project managers, sterilitiy teams, and maintenance to ensure compliant facility operations.

Requires a science/engineering/manufacturing bachelor's or equivalent, plus extensive experience in quality, validations, and regulatory standards relevant to medical devices and healthcare manufacturing.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing and 7+ years in industry.
• Alternate: HS diploma with 12+ years in science/engineering/manufacturing.

Responsibilities

• Lead cross-functional facilities validations and qualification activities.
• Support requalification and contamination control programs.
• Develop and maintain QMS documents and procedures.
• Lead internal audits and manage CAPAs.

Skills

Quality engineering

Facilities validation

IQ/OQ documentation

CAPA management

Regulatory standards

Education

Bachelor's degree in science/engineering/manufacturing

High School Diploma/GED

Tools

ComplianceQuest

Job description

Solventum, Brookings, SD, seeks a Quality Engineer in QMS/Facilities to lead cross-functional validations, support requalification, and maintain QMS documentation. You will collaborate with project managers, sterilitiy teams, and maintenance to ensure compliant facility operations.

Requires a science/engineering/manufacturing bachelor's or equivalent, plus extensive experience in quality, validations, and regulatory standards relevant to medical devices and healthcare manufacturing.