Sr Quality Assurance Specialist (CAPA) REMOTE

a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; } Senior Quality Assurance Specialist - CAPALocation: 100% RemoteIndustry: Medical DeviceCompensation: $90K-$95K + 5% BonusJoin a leading implantable medical device company as a Senior QA Specialist. In this role, you'll own the CAPA process, support audits, and ensure compliance with ISO 13485 and FDA regulations. This is not a software QA role-it's a hands-on quality position focused on product development, manufacturing, and regulatory documentation.Key Responsibilities:Lead CAPA investigations and corrective/preventive actions.Support internal audits and quality planning.Drive compliance with ISO 13485, 21 CFR Part 820, and cGMP.Collaborate cross-functionally to uphold QMS standards.Participate in audit preparation and continuous improvement initiatives.Qualifications:B.S. in Engineering (EE OR ME preferred)5+ years in medical device or regulated industry (QA CAPA focused!)Strong knowledge of ISO 13485, FDA regulations, and risk management (ISO 14971)Skilled in technical writing, documentation, and problem-solving.Proficient in Microsoft Office; ability to prioritize and multitask.Benefits$90-95k base Depends on Experience + bonusHuge Room for Growth!Bonus OpportunityRegular Company FunctionsVacation/PTOFull Benefits: Medical, Dental, VisionAmazing Work EnvironmentHUGE room for growth (lucrative startup)A team of sharp people on the same missionMust be authorized to work in the US without Sponsorship401(k)

Created: 2026-04-02