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Quality Engineer
Ref No.: 18-00365
Location: Petaluma, California
Position Type:Contract
Start Date: 01/15/2018
Job Category:Non-IT Engineering
Job Responsibilities:
  • Coordinates Petaluma plant activities related to the customer complaints.
  • Coordinates customer-complaint related CAPA (Corrective Action and Preventive Action) program at the Petaluma plant.
  • Works with various departments to identify the root cause of problems, define the necessary actions required to assure corrective and preventative actions are properly implemented and documented.
  • Perform the task of verification of effectiveness of the CAPAs.
  • Administers Quality database programs as part of our quality system.
  • Administers Key Business Metrics and Department Metrics.
  • Works with management and department managers to identify and monitor metrics associated with the various departments
  • Communicate with customers to address the quality issues in a timely and the most effective way.
  • Perform inspection of parts or other necessary tests if needed.
  • Participate in the process and product improvement plans.
  • Participates actively to cost reduction and PPI programs
  • Other duties may be assigned, as required.

  • One year of experience in an ISO 9001 and/or ISO 13485 certified medical-device manufacturing company.
  • Hands-on experience in managing CAPA system.
  • Strong computer skills including data based programs such as excel and access.
  • Experience with FMEA and other preventive-action tools
  • BS in Mechanical or Industrial Engineering or equivalent work experience
  • MS Office (Word, Excel, Access and PowerPoint) Intermediate level.
  • Statistical software and/or databases.
  • Experience will Lean or Six Sigma programs
  • Able to use statistical software such as Minitab or equivalent.
  • Ability to write technical reports.
  • Strong ability to manage personnel, projects and work requirements.
  • Knowledgeable in motivating and positively influencing peers.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and safety documents.
  • Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to effectively present information to groups of employees, other managers and customers.
  • Ability to define problems collects data, establish facts, and draw valid conclusions.