Sr. Quality System Engineer

The Sr. Quality System Engineer will support and enhance the electronic Certificate of Conformance (eCOC) process for U.S. imports, ensuring compliance with CPSC and CBP requirements. The role will involve system enhancements, cross-functional collaboration, and serving as a subject matter expert on COC processes.

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.