Goddard is seeking a Quality Engineer to ensure innovative medical technologies meet the highest standards of safety, security, and regulatory compliance, specifically focusing on the quality, validation, and compliance of software systems within the medical device industry.
Requirements
- 3-5+ years of experience in a software quality, software development, automated testing, or design quality engineering role, specifically within the medical device, pharmaceutical, or healthcare industry.
- Expertise in the validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology.
- Proven experience implementing and working with ISO/IEC 62304 (Medical Device Software Lifecycle), ISO/IEC 14971 (Risk Management for Medical Devices) and ANSI/AAMI SW96 (Security Risk Management for Medical Devices).
- Experience with FDA regulations (21 CFR Part 820), EU Medical Device Regulations (EUMDR), and ISO 13485.
- Demonstrated experience developing and executing manual and automated test suites.
- Experience working in an Agile/Scrum development environment.
- Familiarity with test management tools such as DOORS, Jama, Jira, or Test Track Pro.
Responsibilities
- Develop and Execute Test Procedures: Design, develop, and execute manual and automated software test procedures, scenarios, protocols, and scripts to verify design and product requirements.
- Documentation and Deliverables: Author, review, and approve a range of quality assurance, software validation and verification deliverables, including validation plans, requirement test plans, protocols, results, risk assessments, traceability matrices, and summary reports.
- Regulatory Compliance & Standards Adherence: Monitor and ensure that regulations, protocols, procedures, and methodologies are followed.
- Risk Management: Conduct and participate in product and software risk assessments, including FMEA (Failure Mode and Effects Analysis), to identify potential issues and determine tests to support mitigations.
- Quality System Support & Improvement: Support the writing, deployment, management, and standardization of Quality Management System (QMS) processes, ensuring they are effective and compliant.
- Collaboration and Oversight: Work closely with cross-functional teams, including R&D, NPD, Integration, Software, Machine Learning, and Manufacturing, to assure quality in design for medical devices and application software.
- Change Control: Review and approve change-control requests to assess potential quality system impact and ensure new software or changes are validated before approval and use.
Other
- Bachelor’s Degree in Engineering, Computer Science, IT-related field, or other scientific/technical discipline.
- Excellent communication skills (written and verbal)
- Strong organizational skills
- Keen attention to detail and accuracy
- Demonstrated project management competency.
