Remote Sr. FDA Design Quality Engineer (SW)

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Written by AI from the job title and company, not by Dice, 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 Dice is crucial in ensuring that software products meet the stringent quality standards set forth by regulatory authorities, particularly the FDA. This role involves analyzing, developing, and implementing design control processes, documentation standards, and compliance protocols for software used in medical devices. The ideal candidate will collaborate across functional teams to ensure that product designs satisfy both regulatory requirements and customer expectations, all while promoting a culture of quality and continuous improvement within the organization.

Job Responsibilities

• Develop and maintain design control documentation in accordance with FDA regulations and ISO standards.
• Review and approve software design specifications, verification and validation plans, and test protocols.
• Ensure compliance with risk management protocols throughout the software development lifecycle.
• Conduct design reviews and inspections to ensure regulatory compliance.
• Lead cross-functional teams in the investigation of non-conformances, identifying root causes, and implementing corrective actions.
• Assist in the preparation of submissions to regulatory agencies as needed.
• Provide training and support to teams on quality assurance principles and FDA regulations.
• Monitor changing regulations related to software quality and design controls to ensure ongoing compliance.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field; a Master’s degree is preferred.
• Minimum of 5 years of experience in quality assurance, software development, or a similar role within a regulated industry.
• In-depth knowledge of FDA regulations, ISO 13485, and design control principles.
• Proven experience with software verification and validation techniques.
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent communication skills, both verbal and written.
• Ability to work collaboratively in a remote team environment.

Technologies & Tools

The Sr. FDA Design Quality Engineer utilizes various technologies and tools essential for quality assurance and regulatory compliance. Commonly used tools include Electronic Lab Notebooks (ELN), Quality Management Systems (QMS), version control systems such as Git, and software testing tools like TestRail and Selenium. Familiarity with statistical analysis software and risk management tools is also advantageous for the role.

Ideal Candidates

Ideal candidates for the Remote Sr. FDA Design Quality Engineer position will possess a strong drive for excellence and a proactive approach to problem-solving. They should demonstrate exceptional attention to detail and be capable of translating complex regulatory requirements into actionable quality processes. Strong interpersonal skills are essential for effective collaboration within a team environment. Additionally, candidates should exhibit a passion for continuous learning and improvement in quality practices, exemplifying commitment to delivering high-quality software solutions in a highly regulated industry.