Design Quality Engineer

Quality Assurance Irvine, California


Description

Participates in all aspects of product, process, and supplier development in order to ensure the highest level of quality in new products, and their compliance to applicable regulations and standards.

Responsibilities:

  • Represent Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
  • Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts.
  • Review and approve change orders on assigned projects and product lines.
  • Plan, design, and implement test methods, including test equipment, for inspection of product.
  • Evaluate, update, and improve difficult manufacturing processes and engineering systems for assigned product lines.
  • Work with suppliers to continually improve technical processes, reliability, and inspections to meet Inari’s quality standards.
  • Participates in drafting and implementing risk analysis documentation for new products with identified hazards and harms.
  • Provide leadership and guidance, in the scope of quality systems, to ensure compliance within designated projects and product lines.
  • Apply statistical rationale to plan, analyze, and interpret engineering test data collected during new testing.
  • Performs special projects as assigned. 

Qualifications:
  • Bachelor’s degree in Engineering (mechanical, biomedical, or materials preferred).
  • Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
  • Good knowledge of Design Controls and Risk Management for medical devices.
  • Working knowledge of data collection, data analysis/evaluation, and scientific method.
  • Minimum 5 years’ experience in a quality engineering role.
  • Excellent, proven interpersonal, verbal and written communication skills.
  • Critical thinking skills and good judgment.