Senior QMS & Compliance Specialist

Morgan Stanley; Littleton (CO); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive pay

PTO & holidays

401(k) matching

Health, dental, vision

Global team

Innovative culture

Talent development

Job summary

3D Systems in Littleton, CO is seeking a Senior Quality Systems Specialist to lead and improve the Quality Management System across sites. You will coordinate internal audits, support regulatory inspections, and drive CAPA investigations to ensure compliance and continuous improvement.

The role requires 4–6 years of QMS experience in regulated industries, strong cross‑functional collaboration, and hands‑on QA process management.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 4–6 years of experience with Quality Management Systems in regulated industries.

Responsibilities

• Maintain and improve QMS processes across sites and functions.
• Coordinate internal audit program and corrective actions.
• Support customer, regulatory audits and hosting activities.
• Administer CAPA program including investigations and closures.
• Support supplier qualification and audit activities.
• Manage eQMS validation, testing and continuous improvement.
• Prepare quality metrics and management review inputs.
• Participate in continuous improvement and risk-based quality initiatives.

Skills

ISO 13485

FDA 21 CFR Part 820

MDSAP

AS9100

QMS management

Internal audits

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Life Sciences or related field

Tools

QMS software

Job description

3D Systems in Littleton, CO is seeking a Senior Quality Systems Specialist to lead and improve the Quality Management System across sites. You will coordinate internal audits, support regulatory inspections, and drive CAPA investigations to ensure compliance and continuous improvement.

The role requires 4–6 years of QMS experience in regulated industries, strong cross‑functional collaboration, and hands‑on QA process management.