Quality Systems Engineer - Impactful QA Leader (Onsite MO)

USA SOLVENTUM US LLC; St. Louis (MO); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences and Retirement Benefits

etc.

Job summary

Solventum is seeking a Quality Systems Engineer in Maryland Heights, MO to manage the QMS, ensure regulatory compliance, and support document control. You will host audits, lead internal audits, and drive CAPA processes to improve product quality and patient safety.

The role requires a BS in a science field with 5 years of QMS/regulatory experience or an HS diploma with 8 years. ISO 13485/9001 exposure and strong technical writing are a plus.

Qualifications

• BS in Science or equivalent accredited degree with 5 years in QMS or regulated environments.
• HS Diploma/GED with 8 years of QMS experience.
• ISO 13485, ISO 9001 familiarity and/or pharmaceutical audit/inspection experience a plus.
• Technical writing and CAPA experience are desirable.

Responsibilities

• Manage various elements of the QMS to ensure compliance and continuous improvement.
• Ensure compliance with relevant regulations and standards.
• Create and support QMS document control and change processes.
• Communicate with management about compliance issues or negative trends.
• Host customer audits and regulator inspections for the site.
• Lead internal audits and support reporting and system use/training as needed.
• Oversee document changes efficiently and ensure accessibility in the controlled system.
• Interpret regulations and represent the customer to foster a quality culture across the plant.

Skills

QMS Experience

Regulatory Compliance

Internal Audits

Document Control

CAPA writing

Technical Writing

Audit Coordination

Education

BS in Science (accredited)

HS Diploma/GED with 8 years QMS experience

Job description

Solventum is seeking a Quality Systems Engineer in Maryland Heights, MO to manage the QMS, ensure regulatory compliance, and support document control. You will host audits, lead internal audits, and drive CAPA processes to improve product quality and patient safety.

The role requires a BS in a science field with 5 years of QMS/regulatory experience or an HS diploma with 8 years. ISO 13485/9001 exposure and strong technical writing are a plus.