Sr. Quality System Engineer [Remote]

Job Responsibilities:

• Act as the global subject matter expert for Certificate of Conformance (COC) processes related to U.S. imports.
• Own and continuously improve the end-to-end eCOC workflow, integrating systems such as LIMS, Google Big Query (GBQ), and Veeva.
• Define business and system requirements for eCOC generation, metadata management, test report handling, and full message set creation.
• Ensure alignment of system functionality with CPSC Portal and CBP ACE eFiling requirements.
• Collaborate with laboratories to ensure accurate test report generation and documentation transmission.
• Provide guidance and support to retailers on eFiling requirements, CSV file creation, and troubleshooting submission issues.
• Lead business-side project management for system implementations, upgrades, and regulatory changes.
• Oversee configuration, testing, validation, and user acceptance testing for eCOC-related system updates.
• Support training and Organizational Change Management efforts to ensure users understand test report downloads, COC generation, and CSV file compliance.
• Monitor regulatory updates and assess impacts on systems and processes.
• Serve as an escalation point for complex COC, test report, and importer-of-record issues.

Skills:

• Strong understanding of U.S. import compliance requirements (CPSC, CBP, ACE, and eCOC filings).
• Experience with integrated systems like LIMS, data warehouses, and document management platforms.
• Proficiency in Veeva Vault configuration and administration (preferred).
• Ability to translate regulatory and business requirements into clear technical specifications.
• Strong cross-functional collaboration skills, working with IT teams, external partners, and business stakeholders.
• Strong communication and leadership skills, comfortable leading technical and non-technical meetings and training sessions.
• Project management experience, especially with system implementations or enhancements.
• Familiarity with SAFe Agile methodologies and JIRA.
• Ability to work across global time zones and travel approximately 10%.

Education/Experience:

• Bachelor’s degree in Engineering, Computer Science, Information Technology, or related technical field.
• 5+ years of experience in systems engineering on compliance systems or regulatory technology environments.
• Experience with U.S. import compliance systems, particularly CPSC, CBP, ACE, and eCOC filings, is a plus.
• Experience working with integrated systems like LIMS, data warehouses, and document management platforms.
• Experience in supporting external customers or retail partners in compliance-related processes is a plus.