Sr. Software Quality Engineer

• Sep 2022 - Present

Principal Software Quality Engineer resource, responsible for improving the company’s existing QMS to comply and conform with the FDA regulations, ISO 13485, IEC 62304 and ISO 14971 industry standards. Primary Duties: • Provide gap analysis on existing QMS processes, procedures, and deliverables. • Develop the Non-Product Software procedure and applicable templates. • Write templates for the company’s procedures, work instructions, records, and forms. • Rewrite the exiting Software Development Lifecycle procedure to align with IEC 62304 requirements and address required gaps. • Train and mentor cross-functional software teams on new/revised procedures and on various software development activities and deliverables. Show less

Sr. Software Quality Engineer

• May 2022 - Sep 2022

Principal Quality Engineer resource, responsible for integrating the software development process per IEC 62304 into the company’s existing QMS. Primary Duties: • Reviewed, developed, and revised quality procedures, work instructions, and templates to comply and conform with IEC 62304 standard, 21 CFR 820, ISO 13485, and ISO 14771. • Provide group and individual training on new and revised procedures. • Led and mentored cross-functional software teams on various software development activities and deliverables. Show less

Software Quality Engineer

• Jul 2021 - May 2022

Assisted clients to develop FDA QSR, IEC 62304, and ISO 13485 compliant documentation. Primary Duties: • Audited Design History File for compliance to IEC 62304 and ISO 13485. • Reviewed, updated, and approved design control documents. • Provided guidance on policy and procedure improvement. • Led and mentored software teams, including development lifecycle planning, requirements documents, anomaly analysis, and verification documentation methods. • Reviewed, approved, and audited software design documents. • Provided Arena (Product Lifecycle Management system) configuration settings, validation, and support various Arena change requests. Show less

Senior Quality Engineer

• 2009 - 2021

Managed multiple software product developments to ensure the development processes and documentation comply with ISO 13485, ISO 62304, ISO 14971, and FDA guidelines, in an Agile software development mythology. Trained other software development members on the design control processes. Performed internal audits. Primary Duties: • Worked with cross-functional teams to assure processes for product development, verification, and validation activities comply with company’s standards and regulations. • Represented the Quality Engineering Management at the weekly Risk Assessment Management meetings. • Established and continued improvement of quality standards for products, processes and procedures. • Provided guidance on and supported product release and configuration management procedures. • Performed internal audits and supporting onsite audits. • Provided training on software deployment and design control processes. Show less

Senior Software Quality Engineer

• 2007 - 2009

Verified and validated AboveHealth web applications. Managed a team of six QA engineers, including two oversea contractors. Provided test estimation times and resources for software changes and new requirements. Developed all test documents and reports to ensure that the requirements met and followed the company’s quality standards. Primary Duties: • Created test plans, test cases, test scripts, and reports. • Executed UI and backend/embedded application testing. • Tracked, verified, and reported software issues. • Utilized SQL Query Analyzer to manipulate and validated test data. • Created intra-team training plans. • Participated in high-level designs of new or enhanced application changes. • Trained new team members on software development and testing processes. • Reviewed software requirements and specifications and provided feedbacks. • Involved in multiples cross-functional software development teams. • Participated in interviewing and hiring decision of new members Show less

Quality Assurance Engineer

• 2005 - 2007

Verified and validated client and web applications. Wrote test documents and reviewed software requirements and specifications. Participated in multiples cross-functional software development teams. Trained new QA team members. Primary Duties: • Created test plans, test cases, test scripts, and reports. • Tested on web, desktop and middle-tier service applications. • Assisted in writing and reviewing requirement documents for student loan systems. • Led multiple User Acceptance Testing efforts. • Performed installation and production validation testing. • Set up desktop test environments and machines. • Tracked, validated, and reported software issues. • Utilized SQL Query Analyzer to manipulate and validate test data. • Created a training plan. • Trained new team members on the software development and testing processes. Show less

Software Quality Analyst

• 2004 - 2005

Tested client and web applications on Windows platforms. Wrote various test documents and reviewed software requirements and specifications. Participated in multiples cross-functional software development teams. Primary Duties: • Analyzed and designed test plans, cases, scripts, and reports. • Tracked and reported software defects. • Reviewed, edited, and validated documentation and training/users guides. • Participated in developing process improvements for the Quality Assurance Department. • Led various User Acceptance Testing sessions. Show less

Senior Software Qualtiy Assurance Engineer

• 2000 - 2004

Led and coordinated teams in validating client and web applications on multiple Windows and UNIX platforms. Worked in cross-functional project teams as a representative of Quality Assurance Department to insure the applications meet software requirements and development standards. Primary Duties: • Analyzed the functionality of the software for usability, compliance, and functionality. • Designed acceptance plans, cases, and reports. • Performed verifying and validation and trend analysis. • Reported and tracked software defects. • Reviewed, edited, and validated technical user guides and on-line help systems. • Guided various User Acceptance Testing efforts. • Setup test environments and machines. • Executed installation and production validation testing. • Provided post-implementation support for customers. Show less

Software Quality Analyst

• 1998 - 2004

• Worked with customers and software development staff in various software development phases. • Advised six department development teams throughout the development cycle to ensure the final software package integrated with the database efficiently and maintained data integrity. • Developed healthcare software systems. • Supported the software control, packaging, and release management. • Worked with customers and software development staff in various software development phases. • Advised six department development teams throughout the development cycle to ensure the final software package integrated with the database efficiently and maintained data integrity. • Developed healthcare software systems. • Supported the software control, packaging, and release management.

U.S. Navy - Electrician's Mate, Petty Officer 3rd Class

• Nov 1984 - Nov 1988