Senior Quality Systems Specialist

3D Systems Corporation; Colorado Springs (CO); In loco; USD 75.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive Pay

Paid Leave (US ONLY)

Flexibility with PTO policy

401(k) with employer matching

Health & Wellness plans: medical, dent

Vision coverage

Short-term and long-term disability

Company-paid basic life insurance

Global team with HQ in Rock Hill

Innovative culture and talent programs

Employee engagement and ERG programs

Descrizione del lavoro

3D Systems Corporation in Littleton, Colorado, is seeking a Senior Quality Systems Specialist to lead and optimize the Quality Management System across sites.

The role requires 4–6 years in regulated industries, strong regulatory knowledge, and hands-on CAPA/SCAR management, with an onsite schedule and a collaborative, fast-paced environment.

Competenze

• Bachelor’s degree in Engineering, Life Sciences, or related field, or equivalent combination of education and experience.
• 4–6 years of experience with Quality Management Systems in regulated industries (e.g., Medical Device, Aerospace, or Industrial Manufacturing).
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR, and/or AS9100.
• Hands-on experience managing SCARs, CAPAs, or driving continuous improvement of QMS processes.

Mansioni

• 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.

Conoscenze

QMS knowledge

Audit coordination

CAPA management

Regulatory compliance

Cross-functional collaboration

Attention to detail

Communication skills

Formazione

Bachelor's degree

Equivalent experience

Strumenti

eQMS

Descrizione del lavoro

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.
• 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!
• Talen 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.

Primary LocationUS-CO-Littleton

Work LocationsUSA-CO-Littleton

Job LevelIndividual Contributor

Job PostingSep 23, 2026, 12:31:11 PM

3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin or because he or she is an individual with a disability or a disable veteran, Armed Forces service medal veteran (referred to collectively as "protected veterans"). The Company also provides applicants with equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including, but not limited to, lactation.