Quality Assurance Specialist

A Day In The Life Of Our Quality Assurance Specialist:

• Support the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes in compliance with applicable regulatory and quality system requirements
• Partner with cross-functional teams to facilitate the timely execution of 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)
• Cookordination and support CAPA activities by tracking timelines, following up on deliverables, identifying risks to completion, and helping drive records toward timely closure
• Maintain and improve quality system procedures, work instructions, templates, forms, and records to ensure clarity, compliance, and process effectiveness
• Support change control activities, including document revisions, implementation tracking, and cross-functional coordination
• Perform data analysis, trending, and reporting of quality metrics to identify systemic issues, monitor performance, and support continuous improvement initiatives
• Support internal and external audits, and regulatory inspections, including preparation of documentation and follow-up activities
• Perform inspection readiness and help 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

Requirements

• Bachelor’s degree in Life Science, Engineering, Quality, or a related technical discipline with 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, including good documentation practices and risk-based decision making
• 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
• Self-starter with the ability to manage multiple priorities, work independently, and drive tasks to completion in a fast-paced environment
• Strong written and verbal communication skills with the ability to collaborate effectively across departments and provide coaching on quality system expectations
• Detail-oriented with a commitment to accuracy, compliance, and high-quality documentation

Qualifications

• May include other duties as assigned by Management

Skills

• Strong analytical, problem-solving, organizational, and communication skills
• Attention to detail and accuracy
• Ability to manage multiple priorities and work independently
• Effective collaboration and communication skills

Benefits

• Competitive salary
• Comprehensive health insurance including Medical, Dental, and Vision
• HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental)
• 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
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events

Pay

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including:

• Competitive salary
• Comprehensive health insurance including Medical, Dental, and Vision
• HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental)
• 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
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events