Title: Software Quality Engineer
Location: Carlsbad CA
Duration: 12 Months Contract
· 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.
• 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 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.
• 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
· BS in Software related disciple or equivalent work experience.
· 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 firstname.lastname@example.org
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,
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-943-4054 / Fax 510-623-5055