Principal Quality Engineer

Posted 18 April 2024
Salary $150,000-190,000
LocationLaguna Hills
Job type Permanent
Contact NameMelody Lam

Job description

The primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly operations. Continual improvement of methods & systems towards full compliance and world class manufacturing.

Duties and Responsibilities:

  • Daily support of production requirements and issues through active involvement & presence in the assembly operations and clean rooms.

  • Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.

  • Maintain the CAPA system and files. Coordinate CAPA activities including investigations, root cause analysis, and implementation of corrective actions with effectivity analysis.

  • Develop quality assurance specifications, test devices & methods, inspection procedures, sampling plans and related written procedures.

  • Support new product launch, Risk Management Activities (FMECA), Master validation plans, product V&V, Process Validations, and Design Transfer into manufacturing.

  • Implement and review changes to existing products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.

  • Support Internal Audit process and follow-up on Audit findings.

  • Manage the Supplier Evaluation and Qualification process. Work with purchasing to manage the qualification process of new suppliers and re-evaluation of existing suppliers.

  • Support & develop quality metrics and monitor production/product non-conformance trends in order to alert senior management of these trends so corrective actions can be implemented.

  • Recommends modifications of existing quality or production standards to achieve optimum quality and compliance.

  • Provide quality engineering support to quality control and provide guidelines on inspection methods and equipment used including measuring systems capabilities.

  • Complete projects in a manner consistent with corporate objectives.

  • Work with Manufacturing and Engineering teams to coordinate pilot production of new process validations and risk analysis activities.


  • Bachelor’s degree (B.S.) & Five (5) years minimum experience in quality engineering and quality assurance.

  • Current knowledge of FDA Quality System Regulations and Guidelines, ISO 13485, and standards applicable to company products.

  • Knowledge and understanding of Quality and Regulatory concepts and application

  • Strong analytical, planning and organizational skills

  • Strong interpersonal and communications skills (oral & written)

  • Self-starter with ability to work independently under pressure and react quickly to changing priorities

  • Proficient in MS Office products.