Quality Assurance Specialist - Operations
On-siteJohns Creek, Georgia, United States
Job Summary
Execute quality control checks on device workflows and documentation to ensure compliance with FDA, ISO 13485, and 21 CFR Part 820 regulations. Review and maintain quality records including CAPAs, NCRs, deviations, and complaint files while supporting internal and external audits. Monitor product performance metrics to flag quality risks and collaborate cross-functionally with R&D, Clinical, and Regulatory teams on initiatives. Contribute to root cause analysis and corrective/preventive action development, ensuring standard operating procedures are followed and version-controlled. Assist with complaint handling investigations and supplier/vendor quality reviews to maintain system integrity.
Required 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
Desired Qualifications
- ASQ certification (CQA, CQE) a plus
- Experience in cardiac monitoring, remote patient monitoring, or connected medical devices
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