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.

Job Overview

The Remote Sr. FDA Design Quality Engineer (SW) at Kforce Inc. plays a pivotal role in ensuring that software design and development processes adhere to regulatory and quality standards set forth by the FDA. This position requires a thorough understanding of software quality assurance principles as well as design control methodologies to ensure that software products are both safe and effective for use. The candidate will collaborate with cross-functional teams to oversee product lifecycle, from conception to post-market surveillance, ensuring compliance and quality are maintained consistently throughout.

Job Responsibilities

• Develop, implement, and manage quality assurance processes according to FDA guidelines.
• Participate in the design control process, including risk analysis, requirements definition, and verification/validation activities.
• Conduct design reviews and audits to ensure compliance with internal and FDA regulations.
• Lead root cause analysis and corrective action initiatives for software quality issues.
• Collaborate with project managers and engineering teams to define quality metrics and requirements.
• Prepare and maintain design documentation, change control records, and quality management system documentation.
• Provide training and support to team members on quality processes and regulatory requirements.
• Stay updated on industry trends and regulatory changes impacting software quality assurance practices.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field.
• 5+ years of experience in quality engineering, particularly in FDA-regulated environments.
• Strong knowledge of software development life cycle (SDLC) and associated methodologies.
• Proficiency in FDA regulations related to software, including 21 CFR Part 820 and ISO 13485.
• Experience with risk management tools and techniques, such as FMEA and fault tree analysis.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills, with the ability to work collaboratively across teams.

Technologies & Tools

The candidate will be expected to utilize various technologies and tools such as electronic quality management systems (eQMS), requirement management tools, risk management software, version control systems, and project management platforms. Proficiency in programming languages such as Python or C++, as well as familiarity with automated testing frameworks, will be advantageous in ensuring robust quality assessments.

Ideal Candidates

An ideal candidate for this position possesses a proactive and detail-oriented mindset, demonstrating a strong commitment to achieving quality standards and regulatory compliance. They thrive in a collaborative environment, are adept at managing multiple projects simultaneously, and possess strong leadership qualities that inspire and motivate team members. A continuous improvement mentality paired with a passion for quality and innovation in software design is critical for success in this role.