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Quality Engineer 2

Location: San Diego, California Salary: bonus
Sector: Quality Assurance (QA) Type: Permanent

Quality Engineer 2 responsibilities:

  • Develop sample plan and data analysis for design verification, new and existing product test methods and incoming inspection
  • Ensure products and processes are in compliance with requirements of quality management system and regulatory agencies
  • Identify and participate in continual improvement activities to enhance the quality system
  • Author, review and approve validations ensuring systems, utilities and processes comply with regulations and standards; participate on validation project teams
  • Work with cross-functional teams to solve problems related to product or process issues; investigate non-conformance's, identify root cause, and determine/implement appropriate corrective action plans
  • Assist with the development and implementation of statistical process controls
  • Assist with quality planning activities to ensure design control and risk management compliance according to regulations
  • Update SOPs to maintain the quality management system
  • Monitor product quality to ensure product compliance; work to identify and implement improvements
  • Participate in internal and external audits
  • Prepare engineering reports and CAPAs as needed
  • Assist with cross-functional training to build quality awareness
  • Complete investigations for confirmed complaints when necessary

Background experience:

  • B.S. and 3-5+ years of experience in a regulated medical device or diagnostic environment
  • ASQ certification, Six Sigma Green/Black belt, and design of experiments (DOE) a plus
  • Proven knowledge of Quality System Regulations
  • Experienced in statistical sample analysis and validation
  • Knowledge of Microsoft Office
  • Knowledge of statistical software, and experienced with ERP system.

Sthree US is acting as an Employment Agency in relation to this vacancy.