Senior FDA Design Quality Engineer - Remote

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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 Senior FDA Design Quality Engineer at Kforce Inc. is responsible for leading and ensuring compliance with FDA regulations throughout the product development lifecycle. This role involves collaborating with cross-functional teams to develop and implement quality systems and processes that meet regulatory standards. The ideal candidate will leverage their expertise in design control, risk management, and quality system documentation to enhance product quality while facilitating the timely delivery of medical devices and solutions to market.

Job Responsibilities

• Develop and maintain design quality plans and ensure compliance with FDA and ISO regulations.
• Collaborate with design and development teams to review design inputs and outputs, ensuring they meet quality specifications.
• Lead risk management activities, including the preparation and review of Design Failure Modes and Effects Analysis (DFMEA).
• Facilitate design reviews and ensure timely resolution of issues identified during the design and development phases.
• Review and approve design validation and verification plans and test protocols.
• Monitor and assess quality metrics to identify areas for improvement within the product development process.
• Provide training and guidance on quality system requirements and best practices to team members.
• Conduct internal audits and assist in external regulatory audits, ensuring all findings are addressed and documented appropriately.

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, or related field; Master's degree preferred.
• A minimum of 5 years of experience in design quality engineering within the medical device industry.
• Strong understanding of FDA regulations including 21 CFR Part 820 and ISO 13485 standards.
• Proficient in risk management techniques and design control processes.
• Excellent analytical skills with attention to detail for documentation and processes.
• Effective communication and collaboration skills to work with cross-functional teams.
• Experience with quality management systems (QMS) and auditing practices.

Technologies & Tools

The Senior FDA Design Quality Engineer will utilize various technologies and tools including but not limited to: quality management systems (e.g., MasterControl, TrackWise), statistical analysis software (e.g., Minitab), electronic documentation tools, and risk management software compliant with FDA standards. Familiarity with design control tools, PLM systems, and other regulatory compliance software will be advantageous.

Ideal Candidates

The ideal candidate for the Senior FDA Design Quality Engineer position possesses a strong combination of technical expertise and interpersonal skills. They should demonstrate a proactive approach to problem-solving and possess the ability to thrive in a fast-paced environment. High levels of organization and communication are essential, along with a commitment to maintaining high standards of quality and compliance. A collaborative mindset, coupled with a focus on continuous improvement, will contribute to the success of both the individual and the team.