Software Quality Engineer

Title: Software Quality Engineer
Location: Carlsbad CA
Duration: 12 Months Contract
 
Job Description:
·         Provide quality software 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.
 
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++.
•         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 3 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.     
 
Physical requirements:
·         This position functions in an environment that requires the ability to interface with standard office equipment such as computers, printers, copiers, fax, telephones, etc. 
·         Position will spend periods of time sitting, standing, walking, etc., as part of the normal conduct of daily business affairs. 
·         Lifting up to 25 lbs
 
If you are available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please send the updated resume to srini@apninc.com along with a best time and number to reach you.
 
Your prompt response is highly appreciated. 
 
Thanks and have a blessed day ahead.
 
-
Thanks and Regards,
Srinivas Mallipog
Resource Executive
APN Software Services, Inc (www.apninc.com)
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-943-4054 / Fax 510-623-5055 
Email Id: srini@apninc.com

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