Software Quality Assurance Engineer # JN -122018-43575

Carlsbad, CA

Posted: 12/06/2018 Industry: QA Testers Job Number: JN -122018-43575
Job Description:
  • Provide software quality engineering support in design and development of medical device products. Facilitate the application of software design controls in product development and sustaining changes

Essential Functions:
  • Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
  • Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
  • Review new and modified product designs for quality characteristics, testability and traceable to product requirements
  • Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance
  • Review Design History Files and Technical Files for conformance to applicable requirements
  • Assist, when appropriate with internal and supplier audits
  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
  • Contribute to software life cycle process improvements
  • Responsible for validating internal Quality System Applications/Tools
  • Create all required documents for Intended Use Validation of Quality System Tools

  • Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing
  • Understanding of Object-Oriented Programming
  • Proficient in LabVIEW and C++
  • Experience with analysing data from SQL databases and writing SQL queries
  • Understand the processes and intent of all aspects of the QMS related to Design Controls
  • In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 and the Medical Device Directive
  • Skilled in test plan development and root cause/failure analysis
  • Good verbal (including presentation) and written communication skills, especially technical report writing.
  • Ability to effectively work on project teams

  • Minimum 2 years of software quality engineering experience or equivalence

Preferred Skill Set:
  • Familiarity with regulatory requirements e.G. IEC 62304, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971
  • Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment
  • ASQ CQE, CSQE certification desirable, but not essential
  • National Instruments TestStand, LabVIEW knowledge and experience highly desirable
  • Experience with Software Reliability

  • BS in Software related disciple or equivalent work experience
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