Quality Engineer

2 weeks ago

Irvine, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

  • Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
  • Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development.
  • Oversight, from a Quality NPD perspective, of the Non-Conformance Report (Client) process for BWI facilities located in the U.S.
  • Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
  • Write, review and/or approve process and product validation protocols and reports, engineering change orders.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
  • Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
  • Ensure that development activities follow design control requirements (Design Trace Matrix).
  • Technical problem solving, failure analysis, and root cause determination.
  • Makes decisions independently on engineering problems and methods and represents the organization.
  • Recommend issue resolution to management for significant capability and compliance issues.
  • Works closely with functional leadership in planning and executing project milestones.
  • Carries out complex or Client assignments requiring the development of new or improved techniques or procedures.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
  • Responsible for communicating business related issues or opportunities to next management levels.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Requirements:

  • Knowledge of Medical procedure and corresponding Medical Equipment
  • Knowledge of Medical Equipment manufacturing processes
  • Knowledge on Quality Management and its tools & techniques
  • Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations
  • Knowledge on Medical Device Regulatory Standards, MDD and MDR
  • Knowledge on NC, CAPA, Audit processes
  • Knowledge in Statistic, Risk Management and Design control
  • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills

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