Neural Analytics, Inc. is a Los Angeles-based medical robotics startup developing and commercializing technologies to measure and track brain health. The company’s technologies integrate ultrasound, robotics and machine learning to empower neurologists with critical information about brain health to make clinical decisions and improve patient outcomes.
We are currently seeking a Senior Quality Engineer who will lead critical quality management system processes including internal audits and CAPA. In addition, this position will support the continuous improvement of manufacturing processes by performing process audits, developing process validations, and driving root cause investigations of nonconforming material.
- Schedules, manages and conducts audits of Neural Analytics activities to assess compliance to all applicable Standards, Regulations, and Neural Analytics Requirements.
- Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action.
- Responsible for reporting of quality trends and information to management on the performance of suppliers.
- Resolve non-conformances during incoming inspection, in-process inspection, and final acceptance testing, including troubleshooting of QC inspection methods.
- Identify / drive root cause analysis, corrective action and preventive action implementation to address nonconformances, customer complaints, audit observations, etc.
- Expected travel for this position is approximately 25%-40%.
- Bachelor's degree in engineering or a related field and 7+ years of experience in medical device industry is required.
- Direct experience with supplier producing product and parts in a regulated environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred.
- Must have knowledge of Quality Engineering discipline, including formal problem solving (i.e. DMAIC, Six Sigma, etc).
- Experience with supplier audits strongly preferred.
- Strong working knowledge of statistics, CQE preferred.
- Competent in Audit, CAPA, Equipment Validation, Inspection Techniques.
Neural Analytics, Inc. takes pride in their employees and offers a variety benefits, wellness programs, and company perks including:
- Competitive Medical, Dental, and Vision plans
- Life insurance
- Flexible Spending Accounts
- Generous PTO
- Paid Holiday and Sick Days
- Team Bonding Events
- Promote from Within
Neural Analytics is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Neural Analytics does not accept unsolicited resumes from search firm recruiters. Fees will not be paid in the event a candidate submitted by a recruiter without an agreement in place is hired; such resumes will be deemed the sole property of Neural Analytics.