Genomic Health is seeking a Senior Software Quality Assurance Engineer to provide leadership, support, and active participation in the development, application, and continuous improvement of Genomic Health's policies, procedures, systems, and controls used in software development. The focus of this position is the collection of software systems used in our human diagnostic products and services.
You will collaborate closely with many different cross-functional teams spanning IT, Product Development, Process Engineering, and other departments, ensuring that these software systems are developed, validated, implemented, and maintained in accordance with internal Software Development Life Cycle (SDLC) processes which ensure compliance to ISO 13485, US FDA QSRs and recognized software development standards.
You will report to the Sr. Director of Quality Assurance.
- Author and maintain policies to guide software and systems development and ensure compliance with relevant regulatory rules
- Provide leadership in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across the company, including:
- Risk Management
- Systems Validation
- Good Documentation Practices within Systems Development
- Quality Investigations
- Record keeping
- Software Design
- Partner with IT, R&D, Process Engineering, and other departments on development, training, and rollout of a compliant SDLC program
- Working with appropriate product/engineering teams, ensure proper risk assessment is performed and documented for new/revised software and systems
- Guide development teams on producing software design documentation that is compliant with ISO 13485, FDA QSRs, IEC 62304 and internal procedures.
- Help develop and perform software validation test scripts
- Support the installation and validation of computer software systems
- Support investigations related to software product and service issues and ensure proper documentation of the investigation and corrective actions
- Other tasks and responsibilities as assigned
- BA/BS Computer Engineering, Engineering, or equivalent combination of education and experience
- Minimum of Eight years of Software Quality Assurance experience preferably in a regulated medical device/diagnostic environment, and experience with a software and systems component included as part of the device
- Experience with development and validation of software in compliance with the requirements of FDA 21 CFR Part 820, ISO 13485, or both
- Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
- Experience with software system validations and risk assessments
- Excellent verbal and written communication
- Attention to detail personality, strong organizational skills
- Ability to work as part of a team
- Software certification (for example ASQ CSQE)
- Experience with CLIA, CAP, and New York requirements for Clinical Laboratories
Travel, Physical/Mental Demands and Work Environment:
- Travel Requirements: 0 - 10% % travel
- Standing or sitting for long periods of time may be necessary in general office environment
- Use of computer, and or telephone for long periods of time may be necessary.
- Considerable periods of time may be spent concentrating and or analyzing data.