Quality Assurance Specialist

Noah Medical; San Jose (CA); Hybrid; USD 75,000 - 94,000; Full time

Benefits offered by this job

Health insurance

Equity program

Life & Disability insurance

Mental health support

Paid holidays

Parental leave

Snacks & beverages

Learning & development

Team events

Job summary

Noah Medical is seeking an QA professional to join our Quality team, focusing on QMS processes and regulatory alignment. You will drive CAPA activities, investigations, change control, and documentation improvements to ensure audit readiness.

The role emphasizes data-driven quality improvements, cross‑functional collaboration, and adherence to FDA/ISO standards in a fast-paced medical robotics environment.

Qualifications

• Bachelor's degree in Life Science, Engineering, Quality, or related technical field with 2–5 years in regulated QA/QMS.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and documentation practices.
• Experience with CAPA, investigations, change control, document control, training, and nonconformance.

Responsibilities

• Support QMS processes for regulatory and quality system compliance.
• Collaborate cross‑functionally to execute CAPA activities with tracking and closure.
• Assist quality investigations including root cause, risk assessment, and verification of effectiveness.
• Coordinate CAPA timelines, deliverables, and records closure.
• Maintain quality system procedures, forms, and records for clarity and compliance.
• Support change control, document revisions, and cross‑functional coordination.
• Analyze data, trends, and quality metrics to identify system improvements.
• Assist audits and regulatory inspections with documentation and follow‑up.

Skills

QA experience

CAPA

QMS

Document control

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Life Science/Engineering

Tools

Arena PLM

MS Office

Job description

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands‑on, technical, and solution‑oriented, and accountable team, seeking like‑minded individuals to join us. Utilizing a data‑driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

Responsibilities

• 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 QMS/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.

Pay Transparency

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including competitive pay, health insurance, 401(k) 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.

$75,000 - $94,000 USD

Benefits & Perks (For Full‑Time Employees)

• 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
• Learning & Development Opportunities: On‑demand online training and book reimbursement
• Team building and company organized social and celebration events

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.