Remote Sr. FDA Design Quality Engineer (SW)

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Written by AI from the job title and company, not by Kforce Inc, so some details may not match this job. The employer's own page has the real description.

Overview

The Remote Sr. FDA Design Quality Engineer (SW) at Kforce Inc. is primarily responsible for ensuring compliance with FDA regulations and quality standards during software development processes. The role focuses on collaborating with cross-functional teams to identify quality requirements, implement effective validation strategies, and support continuous improvement initiatives. By leveraging regulatory knowledge and engineering principles, the engineer will help design, develop, and maintain software products that meet quality benchmarks and regulatory expectations.

Job Responsibilities

• Develop and implement software quality assurance methodologies and processes in accordance with FDA regulations.
• Conduct risk assessments and create risk management plans to ensure product safety and efficacy.
• Collaborate with engineering, design, and testing teams to define quality requirements and ensure compliance throughout the software development lifecycle.
• Perform design and process validation activities, including planning, execution, and documentation of validation protocols.
• Review and approve design control documentation, including requirements specifications, verification, and validation plans.
• Lead root cause analyses for non-conformance issues and implement corrective and preventive actions.
• Monitor and analyze quality metrics and provide insights for continuous improvement initiatives.
• Support audits and inspections by regulatory bodies and provide necessary documentation and evidence of compliance.

Qualifications

• Bachelor's degree in Biomedical Engineering, Computer Science, Software Engineering, or a related field.
• A minimum of 5 years of experience in FDA regulated environments, specifically in software development and quality engineering.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards.
• Proven experience with software validation and quality assurance methodologies.
• Strong analytical and problem-solving skills with the ability to work collaboratively in a team-oriented environment.
• Excellent communication skills, both verbal and written.
• Certifications such as Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) are preferred.

Technologies & Tools

The Remote Sr. FDA Design Quality Engineer will utilize various technologies and tools to facilitate effective quality assurance and compliance processes. This includes software development tools such as JIRA for project tracking, Confluence for documentation management, and statistical analysis software for data evaluation. Additionally, proficiency with validation management tools and quality management systems (QMS) will be essential for overseeing compliance documentation and quality metrics.

Ideal Candidates

Ideal candidates for the Remote Sr. FDA Design Quality Engineer position should exhibit strong organizational skills and a meticulous approach to quality assurance. They should possess a proactive mindset and the ability to take initiative in addressing quality challenges. Furthermore, excellent interpersonal skills to foster collaboration across departments are essential. A genuine passion for enhancing patient safety and product quality in the healthcare technology sector is also crucial for success in this role.