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