QUALIFICATIONS
Required Work Experience:
- BS degree, in an engineering/scientific/computer system/ or quality management curriculum or equivalent experience.
- A minimum of 8-10 years’ work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
- Experience with Hazard Analysis (HA), and Failure Mode and Effect Analysis (FMEA)
- Experience with medical device software development.
- Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.
- Experience with software mobile applications, cloud-based systems, and cybersecurity.
- Experience in the development and implementation of effective Design Control Systems.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
- Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for ssPMAs, and 510(k).
Preferred Work Experience:
- Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
- Experience with software development lifecycles with emphasis on the software quality engineering aspects.
Physical and Mental Requirements:
- Capability to move around the lab space and various environments including warehouse, laboratory, office.
- Strong attention to detail for thorough analysis of quality data and documentation.
- Excellent problem-solving skits to identify and address quality issues effectively.
- Ability to work under pressure and meet deadlines, maintaining accuracy.
- Strong communication skills to collaborate with various teams and present finding effectively.
Knowledge:
- Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, and FMEA
- Experience in the development of system architectures
- Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.
- Experience with electronic Quality Management Systems
- Software validation practices, methodologies, and techniques, preferably in validating medical devices.
- Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.
- Experience in leading internal/External audits and regulatory inspections.
Skills:
- Effective verbal and written communication skills
- Experience collaborating and communicating with individuals at multiple levels in an organization.
- Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
- Strong analytical and problem-solving skills.
- Able to work effectively in a high-stress, high-energy environment.
- Ability to influence people and projects in a fast-moving environment.
EDUCATION
Bachelor’s Degree(Required)
LICENSECERTIFICATIONS
Quality Engineer (CQE)
Six Sigma Certified Black Belt
Six Sigma Certified Green Belt