Software Quality Assurance Eng

Software Quality Assurance Eng I
Carlsbad CA
4 months contract to start with


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. 

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 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. 

Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar

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