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Reference # : 18-36516 Title : Sr Quality Engineer
Location : Northridge, CA
Experience Level : Start Date / End Date : 07/23/2018 / 01/25/2019  
Company: Artech Information Systems
Job Title: Senior Quality Engineer
Location: Northridge, CA
Job ID: 18-36516
Duration: 6+ months
Position Responsibilities:
  • Supporting Manufacturing through implementation of improved Production and Process Controls
  • Managing projects using Problem Solving and Statistical Tools while keeping to Predefined Deadlines
  • Maintaining Risk Management Documents for Released Product (includes Risk Managements Plans/Reports, Risk Analysis Documents, Risk Management Files, dFMEA and pFMEA)
  • Providing support with review and execution of Process and Test Method Validations
  • Providing support to manufacturing line, non-conformances and dispositions
  • Support manufacturing line with possible coverage of second shift and weekends.
  • Performs other related duties as assigned
Basic Qualifications:
  • Bachelor of Science Degree in Engineering or Science-related field and 4 years work experience in Quality Assurance or Quality Engineering OR Master of Science Degree in Engineering or Science-related field and 5+ years’ work experience in Quality Assurance or Quality Engineering
  • Work experience in medical device in a manufacturing environment with production and controls.
Desired/Preferred Qualifications:
  • 8+ years’ work experience in Quality Assurance and/or Quality Engineering in a regulated environment
  • Experience in FDA 21 CFR Part 820 FDA Quality System Regulation, ISO 14971 risk management and other relevant international standards
  • Certified Lean or Six Sigma Black Belt
  • Project Management experience
  • Experience working with remote suppliers and facilities, both domestic and international
  • Chemistry experience.
  • An ability to interact with personnel on significant technical matters often requiring coordination between organizations
  • Working knowledge of problem solving and statistical methods as applied to process and product quality
  • Proficiency in MS Office, including Word, Excel, Outlook, and PowerPoint
  • Strong English verbal and written communication and presentation skills
  • Self-Starter and accountable, with sharp focus on quality and customer experience
Physical Job Requirements:
  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
  • Occasionally required to reach, climb, stoop, kneel, crouch or crawl.
  • Must be able to work within a Class 1000-Class 10000 clean room environment.
  • Must be able to work in environments such as chemical lab with the appropriate protective equipment or other controlled environments.
  • Employee must occasionally lift and/or move up to 25 pounds.
  • May be required to support Operations during weekends and 2nd shift.
Rajiv Maruthi