Senior Quality Engineer, Product Development (Formulation and Bioproduction)

Department

Quality Assurance

Location

San Diego, California

Job Type

Full Time

ID #

1234556


Cue Health Inc. is seeking to hire a full-time Senior Quality Engineer, Product Development (Formulation and Bioproduction).  This individual will bring expertise in design verification and validation, process validation, analytical performance testing, QC test method and technology transfer in assay development, formulation and bioproduction.

Responsibilities:

  • Lead the process and design validation activities of assay development, lyophilization, formulation, and bio-production
  • Develop the design verification and validation protocol and report including the analytical performance testing
  • Develop the process validation protocol and report including the IQ, OQ and PQ for the equipment and bioproduction processes
  • Develop the QC test methods, and procedures for transfer to production
  • Lead in the design of experiments to guard band or optimize the bioproduction processes
  • Perform the process FMEA for the bioproduction processes and design FMEA for the assay and formulation
  • Lead or support the R&D team in the design development activities to ensure design control deliverables are completed in compliance with standard operation procedures, and applicable regulatory standards and guidelines
  • Responsible for the Design History Files and Device Master Record for the assay development formulation and bioproduction
  • Develop processes and specifications for product Quality Control and design transfer to manufacturing. Troubleshooting of manufacturing issues during commercial production
  • Lead and establish the stability studies program for the materials and products
  • Lead in the data analysis for the product development and manufacturing processes
  • Assist the quality management in special projects

 


Requirements:

  • Degree in Bioengineering, Biochemical Engineering, Biochemistry, or related field. Advance degree a plus
  • Minimum ten years of experience in In-vitro Diagnostic medical device environment in compliance with ISO 13485, 21CFR§820 and §809 is a must
  • Must have a good understanding of CLSI and IVD standards and regulations
  • Familiar with good laboratory practices and BSL levels
  • Familiar with NAAT technology is a plus
  • Experience in statistics, Design of Experiments, Six Sigma methodologies is a plus
  • Excellent written and verbal communication skills
  • Self-motivated to lead individuals & projects while working effectively in a team