Quality Assurance Specialist

Quality Assurance SpecialistSan Jose, CaliforniaWho We AreNoah 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 TeamJoin 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!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 requirementsPartner with cross-functional teams to facilitate the timely execution of CAPA activities, including investigation support, action tracking, effectiveness verification, and closure readinessSupport 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 closureMaintain and improve quality system procedures, work instructions, templates, forms, and records to ensure clarity, compliance, and process effectivenessSupport change control activities, including document revisions, implementation tracking, and cross-functional coordinationPerform data analysis, trending, and reporting of quality metrics to identify systemic issues, monitor performance, and support continuous improvement initiativesSupport internal and external audits, and regulatory inspections, including preparation of documentation and follow-up activitiesSupport inspection readiness and help ensure quality records are complete, accurate, and audit-readyParticipate in continuous improvement initiatives to strengthen quality systems, streamline processes, and improve compliance and operational effectivenessMay include other duties as assigned by ManagementAbout YouBachelor'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 industryWorking knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and applicable quality system requirements, including good documentation practices and risk-based decision makingExperience with Quality Management System (QMS) processes, including CAPA, investigations, change control, document control, training, and nonconformance managementProficiency with eQMS/document control systems (e.g., Arena PLM) and Microsoft Office applicationsStrong analytical, problem-solving, organizational, and communication skills with attention to detailExperience with quality metrics, data trending, and reporting preferredSelf-starter with the ability to manage multiple priorities, work independently, and drive tasks to completion in a fast-paced environmentStrong written and verbal communication skills with the ability to collaborate effectively across departments and provide coaching on quality system expectationsDetail-oriented with a commitment to accuracy, compliance, and high-quality documentationPay Transparency The 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 USDBenefits & Perks (For Full Time Employees): Competitive SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, Flexible Time Off + Sick TimePaid parental leaveIn-office snacks and beveragesIn-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam building and company organized social and celebration eventsNoah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.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.Please visit our Careers Page to view our latest openings.NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.