Senior Quality Systems Specialist

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

What We Are Looking For

We are seeking a highly motivated Senior Quality Systems Specialist with a deep understanding of Quality Management Systems (QMS) in regulated industries such as medical devices or aerospace. The ideal candidate brings hands-on experience managing quality systems, strong cross-functional coordination skills, and a keen understanding of how quality processes drive both compliance and continuous improvement. This is a high-visibility role that requires a proactive communicator capable of managing complex quality deliverables while balancing regulatory rigor with business needs. Join our dynamic team and help shape the future of quality excellence in an environment where your expertise will make a meaningful impact every day!

Onsite

This role has an onsite work schedule requiring the person to be in the onsite location 5 days a week.

What's in it for You!

• Competitive Pay: $75,000 - $95,000 per year. Our employees are the best part of our company. We want you to feel valued, appreciated, and included. Because of this, we make sure your hard work is recognized.
• Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays and a flexible working schedule through our paid time off (PTO) policy. Yep, you read that correctly. We are a Company that values you and makes sure you take time for yourself.
• 401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution.
• Comprehensive Health & Wellness Plans: We offer a comprehensive benefit package that includes medical, dental and vision coverage, company-paid short-term and long-term disability insurance, as well as company-paid basic life insurance that supports you during your career with us. We believe that taking care of our employees is essential, and these benefits reflect our commitment to your health, security, and peace of mind.
• Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 13 countries worldwide. Experience a workplace comprised of talented individuals who are passionate about serving our customers and each other.
• Innovative Culture: Innovation is at the heart of what we do! Since our founding in 1986 by Chuck Hull, the inventor of 3D printing, we have continuously pushed the boundaries of what is possible with additive manufacturing. When you join 3D, you will have the opportunity to work with cutting edge technology in an innovative and collaborative culture!
• Talent Development: At 3D Systems, we invest in talent programs to support employees with opportunities to grow, contribute, develop, and thrive in their careers.
• Connection & Engagement Opportunities: We strive to cultivate an environment where our diverse global workforce can connect and thrive. Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program, are just a few examples of how you will be empowered to build connections, celebrate wins, and make a meaningful impact.

What You Will Do

• Maintain and improve Quality Management System processes across applicable sites and business functions.
• Monitor changes to applicable quality and regulatory requirements and coordinate implementation of updates.
• Coordinate and administer the Internal Audit Program, including scheduling, auditor assignments, audit tracking, and corrective action follow-up.
• Support customer, certification body, and regulatory audits, including preparation, hosting activities, and follow-up actions.
• Coordinate responses to audit findings resulting from customer, certification body, and regulatory audits.
• Own and administer the CAPA program, including facilitation of investigations, effectiveness reviews, metrics, and closure activities.
• Support supplier qualification and supplier audit activities as needed.
• Support administration, validation, testing, and continuous improvement of the electronic QMS (eQMS).
• Support document control and change management processes as required.
• Prepare quality metrics, trend analysis, and Management Review inputs.
• Participate in continuous improvement and risk-based quality initiatives.

What You Will Bring

Education and Experience

• Bachelor’s degree in a relevant discipline (e.g., Engineering, Life Sciences, or related field); or an equivalent combination of education and experience.
• 4–6 years of experience working with Quality Management Systems in regulated industries (e.g., Medical Device, Aerospace, or Industrial Manufacturing)

Required Skills/Abilities

• Strong working knowledge of relevant standards and regulations , including ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR, and/or AS9100.
• Familiarity with planning, conducting, participating or documenting internal audits.
• Hands‑on experience managing SCARs, CAPAs, or driving continuous improvement of QMS processes.
• Comfortable using and maintaining a Quality Management System (QMS).
• Excellent written and verbal communication skills, with a proven ability to collaborate effectively across functions and levels.
• Strong attention to detail and ability to manage multiple priorities in a fast‑paced environment.

Preferred Experience

• Certified Lead Auditor (ISO 13485, ISO 9001, or AS9100).
• Experience supporting third‑party or regulatory audits (e.g., FDA, MDSAP, Notified Body).
• Familiarity with training programs, document control, or change management.
• Experience implementing or upgrading eQMS platforms.

Applications accepted online through October 9th, 2026

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