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About
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 Responsibilities Execute quality control checks on device-related workflows, documentation, and product operations processes to ensure compliance with applicable medical device regulations Review and maintain quality records (CAPAs, NCRs, deviations, complaint files) in coordination with Product Operations and Quality teams Support 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 risks Partner with Product Operations to ensure standard operating procedures (SOPs) are followed, current, and properly version-controlled Assist with complaint handling and investigation processes, ensuring timely and compliant closure Support supplier/vendor quality reviews as they relate to product components or services Contribute to root cause analysis and corrective/preventive action development Maintain training records and documentation to support quality system compliance Collaborate cross-functionally with R&D, Clinical, and Regulatory teams on quality-related initiatives Qualifications Bachelor's degree in a relevant field (Quality, Engineering, Life Sciences) or equivalent experience 2–4+ years of QA experience in medical device, healthcare technology, or a regulated industry Working knowledge of ISO 13485, 21 CFR Part 820, and FDA QSR requirements Experience with CAPA, complaint handling, and document control systems Strong attention to detail and process discipline Ability to work independently in a remote, distributed team environment Excellent written communication skills for audit-ready documentation Preferred ASQ certification (CQA, CQE) a plus Experience in cardiac monitoring, remote patient monitoring, or connected medical devices
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