CSV/Quality Engineer
Seeking a CSV/Quality Engineer to join our client, a global leader in the medical device industry, working in Jacksonville, FL.
The Quality Engineer will provide quality leadership on new product project teams to ensure that medical devices and stand-alone software systems are being designed and validated to meet their intended use. As a Quality Engineer, you will be subject matter expertise in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
Responsibilities:
- Support the design, development and testing of new medical devices. These devices are electro-mechanical systems that are operated by software.
- Ensure that project teams follow the New Product Development processes that pertain to software development.
- Partner with Metrology to refine requirements, and to ensure that architecture/ design documents are comprehensive.
- Facilitate the documentation and tracking of Code Review findings.
- Facilitate software risk assessment sessions and own the development of risk documents.
- Create/review/approve Test Protocols pertinent to system testing.
- Review test case execution results and manage defects.
- Own Non-conformances or CAPAs and drive root cause investigations.
- Perform other related duties as assigned by management.
- Proactively examine processes to identify areas for review, change, or elimination.
Qualifications:
- A minimum of a Bachelors degree in Computer Science, Life Sciences, Engineering or related discipline with at least with 5 years of relevant experience is required
- Experience supporting the testing of electro-mechanical systems that are controlled by software is required.
- Excellent understanding of requirements management, configuration management, Software V&V, automated testing, defect management and software risk analysis is required
- Experience in the Medical Device or Pharma/Life Sciences industry is necessary
- Excellent interpersonal skills and teamwork
- Must have the ability to solicit and document system requirements, and understand system architecture and software designs is preferred
- Must have had the experience designing test strategies based on software architecture, requirements and design is required
- Knowledge of ISO 14971, 21 CFR 820, and 21 CFR 210 and 211 is required.