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Quality Assurance Engineer - Doc Control

Summary:

Neural Analytics, a U.S. based medical device company, is searching for a quality assurance engineer to manage document control for a growing quality management system.  The ideal candidate for this role will have a passion for organization and be an expert user of document control software and processes. This individual will work at our corporate headquarters in Los Angeles, California, USA.

Responsibilities:

  • Assists with the establishment and maintenance of the Quality Management System
  • Provide expertise in controlled document management and quality records management
  • Develop, document, and promote document control best practices
  • Support all QA/RA administrative tasks such as QAP and Work Instruction document generation
  • Administer and manage electronic and hard copy documentation change control
  • Reviews engineering and quality documentation for correctness and compliance
  • Responsible for maintaining the control over documents of external origin (e.g., international standards and regulations)
  • Responsible for maintaining training requirements matrix and ensuring required training is administered
  • Assist Quality in both external and internal audits

Qualifications:

  • Bachelor’s degree in Engineering, or other related Science/Engineering field
  • Minimum 3 to 4 years prior work experience in a highly regulated industry preferred (medical device, aerospace, etc.)
  • Thorough knowledge of quality management systems, document control requirements, and best practices in regulated industries
  • Familiarity with 21 CFR part 820, 21 CFR part 11, and ISO 13485 or other equivalent standards
  • Strong written and verbal communication skills
  • Excellent computer skills, including MS Office and Arena PLM (highly desired)
  • Quality related certifications preferred (ASQ, AAMI, Six Sigma, etc.)

 

About the Company:

Neural Analytics, Inc. is an LA-based medical device company that is addressing a global unmet need for immediate and non-invasive diagnosis of brain disorders, including stroke, dementia and trauma. The company was formed in 2013 and has been cultivating its cutting-edge technology for the past 3 years.  Neural Analytics is an agile and energetic workplace, staffed by a growing, high-performing team.

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