Seeking a strong Sr. QA Software Engineer with extensive knowledge of US FDA Quality System Regulations and ISO 13485 Design Controls. The successful candidate will lead the ongoing implementation and administration of our QMS, ensuring adherence to industry best practices.
KEY RESPONSIBILITIES:
Leading QMS Implementation:
- Oversee the continuous implementation of the Quality Management System (QMS) ensuring complaince with FDA Regulations and ISO 13485 Design Controls.
- Integrate internal and external best practices from the medical device industry into our QMS processes.
- Manage the administration and maintenance of the QMS software to ensure its effective use across the organization.
Collaboration with Software Development Teams:
- Work closely with software development teams to create comprehensive Design History Files (DHFs).
- Develop and maintain detailed documentation including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents.
- Conduct design and code reviews to ensure quality and compliance.
- Manage the Software Risk Management File (RMF), including the development of test protocols and reports.
- Ensure comprehensive traceability matrices are maintained linking all development and testing artifacts.
Qualifications:
- Bachelor’s degree in Health Sciences, Biomedical Engineering, Quality Assurance, or a related field.
- Proven experience with Quality Management Systems, particularly focused on US FDA Quality System Regulations and ISO 13485.
- Strong background in software development processes and documentation.
- Proficient in using QMS software and tools.
- Excellent communication and collaboration skills.
- High attention to detail and adherence to regulatory standards.
- Strong analytical and organizational skills.
