Quality Assurance Specialist

Noah Medical

. Support implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes .

Posted 9/23/2026full-timeRemote • United StatesJuniorMid-Level💰 $96,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management System (QMS) processes, including CAPA, investigations, and change control, while ensuring compliance with FDA regulations and ISO standards. Strong analytical and communication skills support effective collaboration and continuous improvement initiatives.

Highest-signal resume keywords

Quality Management System (QMS)CAPA ActivitiesFDA 21 CFR Part 820ISO 13485EQMS/Document Control Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceRoot Cause AnalysisData AnalysisRisk AssessmentCorrective Action DevelopmentQuality Metrics ReportingChange ControlDocument ControlNonconformance ManagementTraining

Soft Skills

Analytical SkillsProblem-SolvingOrganizational SkillsAttention to DetailCommunication Skills

Tools & Technologies

Arena PLMMicrosoft Office

Industry Keywords

Regulated IndustryQuality SystemsContinuous ImprovementInspection ReadinessAudit Preparation

About the role

Key responsibilities & impact

Support implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes
Partner with cross-functional teams to execute CAPA activities, including investigation support, action tracking, effectiveness verification, and closure readiness
Support and perform quality investigations, including root cause analysis, data gathering, risk assessment, corrective action development, and Verification of Effectiveness (VOE)
Coordinate CAPA activities by tracking timelines, following up on deliverables, identifying completion risks, and driving records toward closure
Maintain and improve quality system procedures, work instructions, templates, forms, and records
Support change control activities, including document revisions, implementation tracking, and cross-functional coordination
Perform data analysis, trending, and reporting of quality metrics
Support internal and external audits and regulatory inspections, including documentation preparation and follow-up
Support inspection readiness and ensure quality records are complete, accurate, and audit-ready
Participate in continuous improvement initiatives to strengthen quality systems, streamline processes, and improve compliance and operational effectiveness
Perform other duties as assigned by Management

Requirements

What you’ll need

Bachelor’s degree in Life Science, Engineering, Quality, or a related technical discipline
2–5 years of experience in Quality Assurance, Quality Systems, or Quality Engineering within a regulated industry
Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and applicable quality system requirements
Experience with Quality Management System (QMS) processes, including CAPA, investigations, change control, document control, training, and nonconformance management
Proficiency with eQMS/document control systems (e.g., Arena PLM) and Microsoft Office applications
Strong analytical, problem-solving, organizational, and communication skills with attention to detail
Experience with quality metrics, data trending, and reporting preferred
Ability to manage multiple priorities, work independently, and drive tasks to completion in a fast-paced environment
Strong written and verbal communication skills and ability to collaborate across departments and provide coaching on quality system expectations
Detail-oriented with a commitment to accuracy, compliance, and high-quality documentation

Benefits

Comp & perks

Competitive salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
401K and stock purchase plans
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, Flexible Time Off + Sick Time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Tuition reimbursement
Flexible approach to work with remote, hybrid, field or office work schedules