Quality Assurance Engineer I Accumetrics
In this role you will serve as a technical resource to product development, manufacturing, and suppliers to improve process capability, reliability, and the quality of products. Develop and execute quality and process improvement plans and root cause analysis.
Administer the Deviation and Non-conforming materials (NCMR) programs. Perform investigations on non-conforming parts. Lead or participate in the implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation. Devise sampling procedures; design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data. Develop and initiate standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields. Provide quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost-effective manner.
Bachelor's Degree in Engineering or Quality related field.
Minimum of 3 years validation experience in a FDA regulated Medical Device, Biotech, or Pharmaceutical organization.
Six Sigma, Lean Manufacturing, and/or Quality Engineering Certification (CQE) or equivalent.
Knowledge of cGMP, QSR/ISO 13485/ISO 14971 regulations in Medical Devices.
Strong knowledge of theory and principles of statistics and statistical process control.
Quality-oriented, high attention to detail, and organized.
Experience working in high performance teams.
Strong written and verbal skills in documentation, communication, and teamwork.
||3985 Sorrento Valley Boulevard |
San Diego, CA 92121