Software Quality Engineer

Title: Software QA Engineer
Location: Carlsbad, CA
Duration: 6 Months

Providing 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. 
 
 To succeed in this role, you should have the following skills and experience 
 
 Skills/Competencies: 
 
 •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++ (Preffered). 
 •Experience with analyzing 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. 
 
 Department Specific/Non-Essential Functions: 
 
 Other duties as assigned with or without accommodation. 
 
 EXPERIENCE 
 
 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 
 
 EDUCATION 
 
 BS in Software related disciple or equivalent work experience. 

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