Shield AISan Diego, California$130k-$240k
$130k-$240kjust now
JobgetherPosted 1d ago
Quality Management Systems Specialist at Jobgether scores 0 out of 100 on AI centrality, which makes it AI Level 1 of 4 (Little AI) on this board. The level measures how much of the work is AI, not seniority.
Remote (US)midFull-time
AI in this role
Manage an ISO 13485-compliant quality management system for a medical device software environment in a remote setting.
iso-13485
quality-managementregulatory-compliancecapadocument-controlaudit-readiness
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Management Systems Specialist based in United States.
This role serves as the operational backbone of a regulated Quality Management System within a software-focused medical device environment. You’ll keep an ISO 13485-compliant QMS running day to day while driving CAPA, NCR, document control, audits, and quality activities tied to software releases. The position offers broad cross-functional exposure, working closely with Engineering, Clinical Affairs, Regulatory, and other teams. You’ll help ensure products are released with complete documentation, traceability, and appropriate quality controls. The role also plays an important part in audit readiness, complaint-handling oversight, training, and continuous QMS improvement. This is a hands-on opportunity for a detail-oriented quality professional who enjoys owning processes, solving compliance challenges, and operating in a remote-first environment.
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A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.
Skills and AI tools this role asks for
Quality ManagementRegulatory ComplianceCapaDocument ControlAudit ReadinessIso 13485
Questions you could be asked
- Tell me about a project where quality management was part of your work. What did you do?
- Tell me about a project where regulatory compliance was part of your work. What did you do?
- Tell me about a project where capa was part of your work. What did you do?
- Tell me about a project where document control was part of your work. What did you do?
- Tell me about a project where audit readiness was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Quality Management, Regulatory Compliance, Capa, Document Control, and Audit Readiness. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.
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