back Back to Jobs

Quality Engineer II

Location: Hercules, CA, United States
Job # 12025750
Date Posted: 03-08-2019
Quality Engineer II - Hercules, CA 94547
Pay Rate $50.00/hour  

Our client is seeking a quality engineer to join the Northern California QA team to support validation/verification activities, including software/spreadsheet, equipment and process validations.  This position will also support change management, CAPA and design control activities across multiple business partners.  
  • Support a variety of manufacturing, product development and improvement projects including those for Life Science and Clinical Diagnostic products to ensure appropriate requirements are met.  Review and approve variety of manufacturing and design history file documentation including validation and verification protocols.  Lead and/or facilitate risk management and usability activities related to manufacturing, design control and design transfer.  Support supplier qualification and management and improvements as required.
  • Identifies and analyzes actual and potential causes of risk, consequences and control measures.  Reviews, approves and updates risk documentation related to design, manufacturing and change control projects.
  • Partners with R&D, engineering and manufacturing to ensure proper application of design control, risk management and usability requirements are met.
  • Skilled in statistical tools and methods related to design control, manufacturing and validation programs, including development, implementation and support of appropriate process monitoring and controls consistent with the level of process/product risks.
  • Manage, review and approve root cause investigations, corrective and preventive actions and product nonconformances.
  • Evaluate and improve existing quality management systems and development of training material as requested.
  • Supporting a wide range of continuous and process improvement initiatives, including creating process flow maps, procedures and training materials.
  • Support other quality and compliance activities as required including supporting audits and inspections.
  • Help to drive and foster a quality environment and mindset throughout the business.
*looking for candidates with validation, risk and design control experience*
  • Bachelor’s degree in a scientific or engineering discipline
  • 2+ years experience or equivalent combination of education and experience
  • Basic knowledge of and application of principles and theories of quality engineering.
  • Advanced understanding of GMP/ISO regulations and validation regulations (ISO 14971, ISO 13485, ISO 62366, MDSAP and FDA 820)
  • Skilled in statistical methods, statistical process control, design control and change management within a regulated environment
  • Preferred experience working in a global multiple-site company with multiple quality systems with working knowledge of the device/drug biotech manufacturing process.
  • Preferred experience working with class II IVD products and research use only products
  • Quality Engineering, Six Sigma Green or Black Belt certification desirable
this job portal is powered by CATS