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)
- Coordinate 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
- Support 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
- May include other duties as assigned by Management
About You - 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
#LI-Hybrid
Pay TransparencyThe Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.
Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.California Pay Range
$75,000-$94,000 USD
Benefits & Perks (For Full Time Employees):- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- 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
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
