Sr. Quality Engineer, Service and Customer Support at Noah Medical

San Jose, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Jan, 26

Salary

135000.0

Posted On

10 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Medical Devices, Robotics, GxP, FDA Regulations, ISO Standards, CAPA, Risk Management, Validation, Lean Methodologies, Six Sigma, Communication Skills, Organizational Skills, Problem-Solving Skills, Project Management, Customer Support

Industry

Medical Equipment Manufacturing

Description

Who We Are 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 The Sr. Quality Engineer, Service and Customer Support is responsible for establishing and supporting quality processes as it relates to NPI, Design Transfer, and Post Market Support. This position provides support to the Noah Medical Service organization. A Day In The Life Of Our Quality Engineer, Service and Customer Support Quality & Compliance Support root cause analysis and corrective/preventive actions (CAPA). Assist in developing, maintaining, and improving SOPs, Work Instructions, FMEAs and related quality documentation. Monitor and report Quality KPIs (e.g., NCR trends, Cost of Quality) and contribute to post market risk management activities Ensure day to day compliance with FDA, ISO, and company quality standards. Support internal audits, inspections, and regulatory readiness. Service & Support Collaborate with Customer Care, Field Service, and Product Support to help evaluate recurring service issues, product performance concerns, and maintenance challenges. Review service records and provide quality oversight in customer communication documentation Provide tools, training, and documentation to ensure service teams can meet quality and compliance expectations. Assist in non-product software validation activities, including protocols, reports, and risk analyses. Continuous Improvement Participate in process improvements using Lean and Six Sigma methodologies. Partner with cross-functional teams (R&D, Manufacturing, Medical Education) to reduce recurring issues and improve serviceability. Communicate feedback from the field to inform design improvements and product reliability. Product Launch & Market Readiness Conduct quality reviews of new product launches and system integrations. Support clinical and technical training evaluations to ensure service teams are prepared. Coordinate with Sales, Marketing, and Training to align on customer-facing quality needs. Qualifications Bachelor’s degree in Engineering or related Science, or equivalent experience. 5+ years in Quality Engineering, ideally in medical devices or robotics. Strong knowledge of GxP, FDA regulations (21 CFR Part 11), IEC 62353, and ISO standards (e.g., 13485, 60601). Experience with CAPA, risk management, and validation (software and process). Proficiency with quality and business systems (e.g., Salesforce, Arena, Jira, Tableau, MS Office). Excellent communication, organizational, and problem-solving skills. Preferred: CQA or Six Sigma certification; project management experience Preferred: Experience with global product launch quality management #LI-Hybrid Pay 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 $108,000—$135,000 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, 15-20 days of PTO + 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. 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.

Responsibilities

The Sr. Quality Engineer is responsible for establishing and supporting quality processes related to new product introduction, design transfer, and post-market support. This role involves collaboration with various teams to evaluate service issues and ensure compliance with quality standards.