Senior QMS Lead: Regulatory Compliance & CAPA Expert

3D Systems Corporation; Littleton (CO); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive Pay

Paid Leave (US ONLY)

401(k)

Health & Wellness Plans

Global Team

Innovative Culture

Talent Development

Connection & Engagement Opportunities

Job summary

3D Systems Corporation in Littleton, CO seeks a Senior Quality Systems Specialist to lead QMS in regulated industries. You will coordinate audits, CAPA, and supplier activities, driving continuous improvement and regulatory compliance across sites.

The role emphasizes collaboration, strong documentation, and proactive communication in a fast-paced manufacturing environment. Onsite work is required five days a week; applicants should be ready to contribute to quality programs immediately.

Qualifications

• Bachelor's degree in a relevant discipline or an equivalent combination of education and experience.
• 4–6 years of experience with Quality Management Systems in regulated industries (medical device, aerospace, or industrial manufacturing).

Responsibilities

• Maintain and improve QMS processes across applicable sites and functions.
• Monitor changes to quality/regulatory requirements and coordinate updates.
• Coordinate and administer Internal Audit Program with scheduling, auditors, tracking, and CAPA follow-up.
• Support audits by customers, certification bodies, and regulators, including preparation and hosting.
• Coordinate responses to audit findings from customer and regulatory audits.
• Own and administer CAPA program including investigations and effectiveness checks.
• Support supplier qualification and supplier audits as needed.
• Assist with eQMS administration, validation, testing, and continuous improvement.
• Support document control and change management processes.
• Prepare quality metrics, trend analysis, and Management Review inputs.
• Participate in continuous improvement and risk-based quality initiatives.

Skills

ISO 13485

FDA 21 CFR Part 820

MDSAP

EU MDR

AS9100

Internal Audits

CAPA/SCARs

QMS Management

Regulatory Compliance

Communication Skills

Education

Bachelor's degree in Engineering, Life Sciences, or related field

4–6 years of QMS experience in regulated industries

Job description

3D Systems Corporation in Littleton, CO seeks a Senior Quality Systems Specialist to lead QMS in regulated industries. You will coordinate audits, CAPA, and supplier activities, driving continuous improvement and regulatory compliance across sites.

The role emphasizes collaboration, strong documentation, and proactive communication in a fast-paced manufacturing environment. Onsite work is required five days a week; applicants should be ready to contribute to quality programs immediately.