Senior QMS Lead — Regulated Industries

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

Benefits offered by this job

Competitive pay

Paid time off

401(k) with match

Health & wellness

Job summary

RiseMe, based in Colorado, is seeking a Senior Quality Systems Specialist to oversee and optimize the Quality Management System across regulated environments. This onsite role requires daily presence in Littleton and a proactive approach to ensure compliance and continuous improvement.

The ideal candidate will bring hands-on QMS experience, ability to coordinate audits, manage CAPA, and drive risk-based quality initiatives in collaboration with cross-functional teams.

Qualifications

• Bachelor’s degree in a relevant discipline or equivalent experience.
• 4–6 years of experience with Quality Management Systems in regulated industries.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR, and/or AS9100.

Responsibilities

• Maintain and improve QMS processes across sites and functions.
• Coordinate updates to regulatory requirements and implement changes.
• Administer internal audit program including scheduling and follow-ups.
• Support audits and host activities with customers and regulatory bodies.
• Coordinate responses to audit findings and corrective actions.
• Own CAPA program including investigations and closure.
• Support supplier qualification and supplier audits.
• Assist with eQMS administration, validation, testing, and improvement.
• Support document control and change management.
• Prepare quality metrics, trend analysis, and Management Review inputs.
• Participate in continuous improvement and risk-based quality initiatives.

Skills

QMS knowledge

Internal audits

CAPA management

Regulatory compliance

Cross-functional communication

Attention to detail

Education

Bachelor’s degree in Engineering/Life Sciences

Tools

eQMS

Job description

RiseMe, based in Colorado, is seeking a Senior Quality Systems Specialist to oversee and optimize the Quality Management System across regulated environments. This onsite role requires daily presence in Littleton and a proactive approach to ensure compliance and continuous improvement.

The ideal candidate will bring hands-on QMS experience, ability to coordinate audits, manage CAPA, and drive risk-based quality initiatives in collaboration with cross-functional teams.