Senior Post Market Quality Specialist

3D Systems • Littleton, CO

20h • $76,000 - $90,000 • Onsite

About The Position

We are seeking a highly organized and quality-driven Sr. Post-Market Surveillance Specialist to lead key quality system processes including complaint handling, CAPA management, field corrective actions, and post-market surveillance (PMS). This role is responsible for ensuring timely and thorough investigations, driving cross-functional root cause analysis, developing PMS plans and reports, managing customer communications, and maintaining documentation that meets global regulatory requirements. The ideal candidate will have experience in regulated industries such as medical devices or aerospace, possess strong problem-solving and technical writing skills, and take a proactive, continuous improvement approach. This is a visible and impactful role that strengthens our quality system, protects customers, and supports regulatory compliance globally.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Competitive Pay: $76,000 - $90,000 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.
• 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.
• Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 15 countries worldwide.
• Innovative Culture: Innovation is at the heart of what we do!
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees