Remote Sr. FDA Design Quality Engineer (SW)

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

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

As a Remote Senior FDA Design Quality Engineer (Software) at Kforce Inc., you will play a critical role in ensuring that product designs meet regulatory standards and customer requirements. You will be responsible for overseeing the quality assurance process during the software design and development phases, conducting risk assessments, and collaborating cross-functionally to implement best practices for compliance with FDA regulations. Your expertise will contribute to the overall success of our technology solutions, aiding in the creation of safe and effective medical devices.

Job Responsibilities

• Lead the quality assurance efforts throughout the design and development of FDA-regulated software products.
• Conduct design reviews, ensure compliance with established processes, and identify risks associated with product design.
• Collaborate with cross-functional teams to establish quality standards and develop validation strategies.
• Prepare documentation as per FDA requirements, including Design History Files (DHF) and Design Control procedures.
• Perform software verification and validation activities, providing oversight for testing strategies.
• Participate in audits and inspections, both internally and by regulatory bodies, to ensure compliance.
• Provide training and guidance to engineering teams on quality engineering principles and regulatory standards.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in quality engineering within the medical device or FDA-regulated industry.
• Strong understanding of FDA regulations, ISO 13485, and related quality standards.
• Experience with software verification and validation processes, including risk management principles (ISO 14971).
• Proficiency in tools for quality assurance, including statistical analysis software.
• Excellent communication and interpersonal skills to interact effectively with cross-functional teams.

Technologies & Tools

The Senior FDA Design Quality Engineer will utilize various technologies and tools to facilitate quality assurance processes. Key software may include code analysis tools, automated test frameworks, and risk management software. Familiarity with electronic laboratory notebooks (ELN) and document management systems tailored for FDA compliance will also be essential to streamline documentation and reporting procedures.

Ideal Candidates

The ideal candidate for this position will possess a proactive attitude towards problem-solving and a meticulous eye for detail. Strong analytical skills and the ability to work effectively within a team-oriented environment are essential. A successful candidate will demonstrate expertise in quality processes and understand the critical nature of compliance in the regulated industry. They should also be adaptable to fast-paced changes, committed to continuous learning, and passionate about improving product quality and safety in the medical technology sector.