Senior FDA Design Quality Engineer - Remote

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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 Senior FDA Design Quality Engineer at Dice will be responsible for ensuring compliance with FDA regulations and quality standards throughout the product development lifecycle. This role encompasses reviewing product designs, creating robust quality assurance processes, and collaborating with cross-functional teams to maintain the highest standards of safety and efficacy. The ideal candidate will utilize their expertise to identify potential risks and implement effective quality management systems, ensuring the successful delivery of innovative medical devices.

Job Responsibilities

• Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with FDA regulations and international standards.
• Conduct design reviews and provide feedback to engineering teams to identify quality risks and areas for improvement.
• Perform risk assessments and failure mode effects analysis (FMEA) during the product development process.
• Coordinate and execute verification and validation activities, ensuring all products meet specified quality requirements.
• Serve as a liaison between different departments to ensure alignment on quality objectives and regulatory compliance.
• Conduct training sessions for team members on quality standards, regulatory requirements, and best practices.
• Prepare and maintain quality documentation, including protocols, reports, and regulatory submissions.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree is preferred.
• A minimum of 5 years of experience in quality engineering within the FDA-regulated medical device industry.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards.
• Proficient in risk management methodologies, including FMEA, and CAPA processes.
• Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
• Excellent communication skills, both written and verbal, to convey complex information clearly and effectively.

Technologies & Tools

The Senior FDA Design Quality Engineer will utilize a variety of technologies and software tools to manage quality processes effectively. This includes risk management software, document control systems, and compliance management tools. Familiarity with statistical software for data analysis and electronic lab notebooks (ELNs) may also be beneficial for performing product evaluations and validations.

Ideal Candidates

Ideal candidates for this role are self-motivated professionals who demonstrate attention to detail and possess a strong quality mindset. They should be adept at navigating complex regulatory environments and have a proactive approach to problem-solving. Successful individuals will also exhibit strong teamwork and leadership skills, enabling them to influence cross-functional teams and drive quality improvements across projects. A passion for innovation in the medical device field and a commitment to maintaining high standards of quality will further distinguish the best candidates.