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

Kforce Inc. is seeking a highly skilled Remote Sr. FDA Design Quality Engineer (SW) to join our dynamic team. In this pivotal role, you will ensure that our software products comply with the stringent standards set by the FDA and other regulatory bodies. You will be responsible for developing and implementing quality assurance processes, performing risk management and validation activities, and collaborating with cross-functional teams to drive continuous improvement in product quality. Your expertise will contribute significantly to maintaining the highest standards of safety and functionality in our innovative software solutions.

Job Responsibilities

• Develop and implement design control processes in compliance with FDA requirements.
• Conduct risk management activities including Hazard Analysis and FMEA.
• Perform and assist in software validation testing, ensuring adherence to established practices.
• Collaborate with product development teams to define and document requirements and specifications.
• Prepare and maintain documentation for quality systems, including design history files and validation protocols.
• Participate in audits and inspections, providing necessary information to regulatory agencies.
• Provide training and guidance on quality assurance practices to engineering teams.
• Facilitate root cause analysis and corrective action processes for non-conformance issues.
• Promote a culture of quality and compliance throughout the organization.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
• A minimum of 5 years of experience in quality engineering within the medical device or regulated software industry.
• Strong understanding of FDA regulations and ISO standards pertaining to software quality assurance.
• Proficiency in risk management methodologies and software validation practices.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional attention to detail and commitment to quality.
• Effective communication skills, both written and verbal, with the ability to work collaboratively in a remote environment.

Technologies & Tools

The Remote Sr. FDA Design Quality Engineer (SW) will utilize a variety of technologies and tools to fulfill their responsibilities. Key technologies include quality management software, electronic document management systems (EDMS), risk management tools, and validation software. Proficiency in Microsoft Office Suite, and familiarity with programming languages such as Python or C++, may also be beneficial for effective collaboration with engineering teams.

Ideal Candidates

The ideal candidate for this position is a proactive and detail-oriented professional who exhibits a commitment to quality and compliance. They are characterized by a collaborative spirit, strong analytical skills, and the ability to work independently in a remote setting. A successful candidate is not only well-versed in FDA regulations but also possesses a passion for continuous improvement and innovation in the field of software quality engineering. Additionally, strong communication and interpersonal skills are crucial for fostering collaboration across teams and with different stakeholders.