Quality Assurance Specialist - Operations

Job DescriptionJob DescriptionJob Title: Quality Assurance Specialist – Product Operations Reports To: Director/Manager, Product Operations (dotted line to Quality/Regulatory as applicable) Location: Georgia On-site FLSA Status: ExemptPosition Summary Zywie, Inc. is seeking a QA Specialist to support Product Operations by ensuring the quality, compliance, and reliability of our remote cardiac monitoring devices and related workflows. This role sits at the intersection of quality systems and day-to-day product operations — verifying that processes, documentation, and outputs meet regulatory requirements (FDA, ISO 13485, 21 CFR Part 820) while supporting the operational cadence of a distributed medical device company.Key ResponsibilitiesExecute quality control checks on device-related workflows, documentation, and product operations processes to ensure compliance with applicable medical device regulationsReview and maintain quality records (CAPAs, NCRs, deviations, complaint files) in coordination with Product Operations and Quality teamsSupport internal audits and prepare documentation for external audits/inspections (e.g., FDA, notified body, ISO surveillance)Monitor product performance and operational metrics, flagging trends that may indicate quality risksPartner with Product Operations to ensure standard operating procedures (SOPs) are followed, current, and properly version-controlledAssist with complaint handling and investigation processes, ensuring timely and compliant closureSupport supplier/vendor quality reviews as they relate to product components or servicesContribute to root cause analysis and corrective/preventive action developmentMaintain training records and documentation to support quality system complianceCollaborate cross-functionally with R&D, Clinical, and Regulatory teams on quality-related initiativesQualificationsBachelor's degree in a relevant field (Quality, Engineering, Life Sciences) or equivalent experience2–4+ years of QA experience in medical device, healthcare technology, or a regulated industryWorking knowledge of ISO 13485, 21 CFR Part 820, and FDA QSR requirementsExperience with CAPA, complaint handling, and document control systemsStrong attention to detail and process disciplineAbility to work independently in a remote, distributed team environmentExcellent written communication skills for audit-ready documentationPreferredASQ certification (CQA, CQE) a plusExperience in cardiac monitoring, remote patient monitoring, or connected medical devices