The Software Quality Engineer will be the system owner for software quality function and play an intergral role in design activities for the site. This position reports directly to the Quality Operations Lead and will serve as the site Software Quality Engineer. The incumbent will plan, organize, and report on all software quality-related activities to assure fulfillment of CFR part 11 and 820, and ISO13485 requirements.
The Software Quality Engineer will develop, modify, and execute software test plans, automated scripts and programs for testing. Maintains documentation of test results to assist in debugging and modification of software. Analyzes test results to ensure existing functionality and recommends corrective action. Consults with development engineers in resolution of problems. Provides feedback in preparation of technical appraisals of programming languages, systems, and computation software. Ensures quality computer integration into the overall functions of scientific computation, data acquisition, and processing.
Directs the activities of a software quality assurance function.
This position is based in Union City, CA.
Key objectives of this position include:
Support Product Development:
- Participate in software product development meetings, such as Design Reviews and Risk Management
- Develop software verification and validation protocols for Abaxis analyzer products; e.g., chemistry algorithms, user interface, external communication
- Execute the approved software V&V protocols.
- Generate software V&V reports.
- Track software defects and change requests in support of software configuration management.
- Review and approve Software Design History File (DHF) documents and ensure compliance to Design Control requirements.
Support Manufacturing and the Quality System:
- Develop software V&V protocols, execute protocols, and generate reports for various Abaxis databases, automation equipment software, test systems, and custom software.
- Utilize databases to analyze data and generate reports in support of Manufacturing, Development, and Quality Assurance.
- Perform software development audits of OEM suppliers
- Ensure effective development, implementation and support for Abaxis’ electronic quality system in accordance with 21 CFR Part 11.
- Facilitate assigned complaint, CAPA and NCMR investigations to root cause and ensure timely and effective closure.
- Track, review and approve Software Change Requests.
- Participate in software development audits of OEM suppliers.
- Work with IT to get the SQL queries written such that desired reports can be generated and validated.
This position will need to achieve results through colleagues with a direct reporting relationship (QA team) as well as indirectly with Global groups such as GSS; VMRA, and GQCA. The successful candidate will need to interact regularly with leadership at the site, particularly site Quality and Functional Leads, Global Regulatory Affairs and Global Manufacturing Technology (GMT).
EDUCATION AND EXPERIENCE
- Undergraduate degree in software engineering.
- Relevant advanced degree preferred
- QP Eligibility desired
- Minimum of 10 years progressive experience in the quality control, quality assurance, manufacturing operations in human or animal health medical device and in vitro diagnostics.
- Recognised Lean Six Sigma Qualification (Green Belt or Black belt) desirable
- Working knowledge of 21 CFR Part 11, 21 CFR Par 820, ISO 13485 and ISO 14971 key principles.
- Experience with software development for embedded systems with a working knowledge of C/C++ and Java programming languages, Agile, and the QNX operating system.
- Capable of development of software quality assurance and software verification & validation tools utilizing Microsoft Excel, Access, and SQL databases.
- Extended experience in implementation of software development and software quality assurance medical device quality system processes including:
- Software life cycle definition including risk management and software hazard analysis, Software requirements definition, Software design descriptions
- Design and Code review
- Efficient strategies for unit, integration, and system level software verification & validation activities
- Configuration management and change control of code and documentation
- Design History File (DHF) software documentation content and maintenance
- Working knowledge related to the following FDA regulations guidance documents: FDA Quality System Regulation, 21 CFR Part 820 Design Control and Automated System Validation requirements
- FDA 21 CFR Part 11, Electronic Records, Electronic Signatures, “General Principles of Software Validation”, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, “Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices”
- Working knowledge of international medical device related software standards including: IEEE Software Standards collection, ISO 14971 for medical device risk management, IEC 60601-1-4 for general requirements for safety for programmable electrical medical systems, IEC 62304 for medical device software life cycle processes
- Extensive experience in the validation of automated systems used in production and implementation of the FDA quality system for medical devices.
- Demonstrated experience with Software Design Control and Risk Management.
TECHNICAL SKILLS and COMPETENCIES REQUIRED
- Fluency in quality systems and regulatory compliance.
- Ability to develop and build a strong leadership team which can support the business
- Exercises Good Judgment and Drives Change
- Strong written and oral communication skills
- Inspires Continuous Improvement and Breakthrough Thinking – utilizing problem solving tools such as Lean and Six Sigma
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
- Proficient in English
- Demonstrated written communication skills, as well as experience with presenting to leadership teams.
- Business Awareness & Continuity
PHYSICAL POSITION REQUIREMENTS
- Union City, California Site based position
- This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information