Quality Systems Specialist

Quality Systems SpecialistReporting to the Quality Assurance Program Manager, the Quality Systems Specialist will assist the Quality Assurance Program Manager in maintaining the company's Quality Management System (QMS) in compliance with ISO 9001. This role will assist with the development, publishing and implementation of company policies and procedures to support the continual improvement of its Quality System and maintain accredited registration in ISO 9001. This position reports to the Quality Assurance Program Manager and is performed from SHI's Piscataway, NJ Knox integration center location.Role DescriptionMaintains policies and procedures relative to the scope of SHI's QMS, along with documenting new policies/procedures in collaboration with SHI Managers. SHI's scope includes all departments in SHI's Integration Center, Integration Data Center, multiple Warehouses, Purchasing, Contracts, and IT (risk and business continuity related).Responsible for document management to ensure processes, documentation, JESs (Job Element Sheets) that are part of the company's QMS are regularly updated for accuracy and suitability.Work closely with other departments to develop and implement processes for ensuring proper documentation and adequate document/record controls.Responsible for management of RCA with CAPA's related to Integration Center and respective warehouse, including, but not limited to:conducting investigations of nonconformances to determine root causecollaborating with other team members of SHI to ensure Corrective and Preventive actions are taken and documented in SHI's CAR / PAR systemconducting a review on effectiveness of actions taken and documenting in SHI's CAR / PAR SystemParticipate in cross function collaboration for identifying and implementing process improvements.Run metrics for trend analysis of, including, but not limited to:incidents/nonconformances and root causeISO Quality Master Metrics sheetDOAsOther tasks and projects as necessary to support the ICS teamTravel locally between SHI central NJ facilities to work with cross functional teams for support with the above-mentioned tasks and activities.Behaviors and CompetenciesInitiative: Can identify opportunities for improvement, propose solutions, and take action without explicit instructions.Time Management: Can generally use time effectively but may occasionally struggle with prioritizing tasks, meeting deadlines, or maintaining work-life balance.Technical Troubleshooting: Can identify complex technical issues, propose solutions, and take action to resolve them without explicit instructions.Willingness to Learn: Can actively seek out learning opportunities but may need guidance to apply new knowledge or skills effectively.Documentation: Can independently create and update documentation, ensuring accuracy and consistency, and can identify gaps or areas needing clarification.Multi-Tasking: Can identify opportunities for task optimization, propose solutions, and manage multiple tasks without explicit instructions.Presenting: Can prepare and deliver presentations, addressing key points and responding to questions with clarity.Detail-Oriented: Can identify errors or inconsistencies in work and make necessary corrections.Communication: Can effectively communicate complex ideas and information, and can adapt communication style to the audience.Skill Level RequirementsThe ability to effectively utilize applications like Word, Excel, PowerPoint, and Outlook to enhance productivity and perform various tasks efficiently - IntermediateAbility to read and interpret technical instructions/manuals, troubleshooting guides, and manufacturer specifications - IntermediateDemonstrated deep technical knowledge and proficiency in multiple technology areas to provide expert guidance and solutions - IntermediateIn-depth understanding of the structured practices and workflows involved in the software development lifecycle, from requirements gathering and coding to testing and deployment - IntermediateDemonstrates expertise in configuring hardware, software, firmware, and related documentation to meet technical requirements - IntermediateApplies knowledge of quality practices to conduct root cause analysis and drive continuous improvement efforts - IntermediateOther RequirementsCompleted Associate's Degree or relevant work experience required2-4 years of experience in a similar role requiredFamiliarity with ISO 9001 Quality Standards preferredAbility to travel between local SHI buildingsExtended hours are required to complete some special projectsPreferredUnderstanding of Internal Auditing, including Root Cause Analysis and 5 Whys AnalysisBackground in providing training or operational supportKnowledgeable and familiar with general Warehouse processesKnowledgeable and familiar with general Production processesThe base salary range for this position is $60,000 - $85,000. The estimated on-target earnings, or OTE, which includes a base salary, are $60,000 - $85,000. The compensation for this position is dependent on job-related knowledge, skills, experience, and market location and, therefore, will vary from individual to individual. Benefits may include, but are not limited to, medical, vision, dental, 401K, and flexible spending.Equal Employment Opportunity – M/F/Disability/Protected Veteran Status