3D Systems Corporation · 4 hours ago
Senior Post Market Quality Specialist
Littleton, CO
Full-time
Onsite
Mid, Senior Level
$76K/yr - $90K/yr
4+ years exp3D Systems Corporation is a leader in additive manufacturing and is seeking a Senior Post Market Quality Specialist to enhance their quality system. The role involves managing quality processes such as complaint handling, CAPA management, and post-market surveillance to ensure compliance with global regulatory standards.
3D Printing3D TechnologyIndustrial EngineeringManufacturingMechanical EngineeringPrintingSoftwareTechnical Support
Responsibilities
Own and oversee the entire CAPA process as CAPA Coordinator, including leading the CAPA Review Board, ensuring CAPAs comply with internal procedures, and verifying technical writing is clear, accurate, and audit ready
Meet regularly with CAPA owners to provide feedback, guide root cause analysis (RCA) using appropriate methodologies (e.g., 5 Whys, Fishbone), and track corrective and preventive action items to ensure timely closure
Own the full complaints handling process, from intake and investigation to closure, ensuring all activities are thoroughly documented, complete, and meet global regulatory requirements
Manage all customer communications related to complaints, including initial acknowledgment, follow-up inquiries, requests for additional information, and providing final investigation results
Collaborate cross-functionally with Quality, Regulatory Affairs, Product Development, Manufacturing, and Service teams to ensure appropriate investigation, escalation, and resolution of product issues
Submit Medical Device Reports (MDRs) and other required regulatory reports (e.g., EU vigilance reports, Health Canada reporting) in a timely and accurate manner
Coordinate and manage Field Safety Corrective Actions (FSCAs) and recall activities, including preparation of regulatory submissions and customer notifications, as needed
Develop, maintain, and execute Post-Market Surveillance (PMS) activities, including PMS plans, PMS reports, and related processes to ensure compliance with global regulatory requirements
Monitor complaint trends, conduct data analysis, and escalate issues as appropriate to drive continuous improvement and product safety initiatives
Serve as Subject Matter Expert (SME) for internal and external audits related to CAPA, complaints, and post-market surveillance processes
Qualification
Required
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 in Quality, preferably with a focus on CAPA, complaints, or post-market surveillance required
Experience in FDA-regulated and/or ISO-certified environments required
Strong attention to detail with technical documentation and writing skills
Proven ability to conduct and document thorough investigations, root cause analyses, and CAPA processes
In depth knowledge of quality system regulations and standards (e.g., 21 CFR Part 820, ISO 13485)
Ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment
Effective cross-functional communication, collaboration, and problem-solving skills
Preferred
Knowledge of FDA 21 CFR Part 820, ISO 13485, and relevant quality system regulations
Experience with AS9100 or aerospace quality systems
Familiarity with Medical Device Reporting (MDR) and vigilance activities
Experience with Post-Market Surveillance (PMS) activities, including reports and trend analysis
Coordination of field corrective actions (FSCAs), recalls, and regulatory submissions
Experience in CAPA, complaint, and PMS processes and audits
ASQ certifications (e.g., CQA, CQE, CSQP) a plus
Benefits
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.
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.
Company
3D Systems Corporation
More than 30 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry.
1001-5000 employees
H1B Sponsorship
3D Systems Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (12)
2023 (8)
2022 (13)
2021 (11)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$386.96MKey Investors
PNC Bank
2025-12-09Post Ipo Debt· $30.77M
2025-06-18Post Ipo Debt· $92M
2021-12-08Post Ipo Equity· $19.76M
Leadership Team
Joe Zuiker
Executive Vice President of Engineering, Operations, & Customer Service
Reji Puthenveetil
Executive Vice President, Additive Solutions & Chief Commercial Officer
Recent News
2026-01-06
MarketScreener
2026-01-05
Company data provided by crunchbase