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Quality Eng Quality Engineer III - CAPA
Ref No.: 18-05185
Location: Hercules, California
Greetings from Intelliswift Software Inc. We are looking for a Quality Eng Quality Engineer III. If interested, please send us your updated resume and a suitable time when we could discuss this opportunity:
 
Description:
  • Oversee customer feedback program including analysis and coordination of escalated customer complaint investigations and analyzing other customer feedback sources (e.g. NPS surveys, etc).
  • Lead Complaint Review Board meetings, trend analysis and presentation of complaint metrics and working with various point people across the organization to plan and document investigations, implement corrective action and verify effectiveness.
  • Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.
  • Present escalated complaints and complaint metrics during external audits and Management Review meetings as requested.
  • Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.
  • Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
  • Evaluate and document risk assessments that drive product disposition and level of corrective action required.
  • Lead post-market Risk Management activities such as updating risk management files and compiling post-market surveillance reports.
  • Evaluate and improve QMS procedures and training materials as required.
  • 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.
  • Other duties as assigned.
  • 5+ years’ experience or equivalent combination of education and experience.
  • Bachelor's degree or equivalent in a related technical discipline.
  • Full knowledge of and application of principles and theories of quality engineering.
  • Thorough understanding of ISO 13485 and GMP regulations is preferred.
  • Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
  • Working knowledge of the device/drug/biotech manufacturing process.
  • Skilled in statistical methods, statistical process control and sampling plans.
  • Experience working with SAP, Salesforce and Power BI is preferred.
  • Understanding of risk management regulations, principles and application.
  • Communication, technical, and computer skills.
  • Experience working in a customer-facing position such as Technical Support is desired.
  • Coordination, tact and team work