Quality Assurance Specialist - Operations

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
• Absorb and 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