Job Description

Medical devices Quality Engineer - NPI, not IT

A rapidly growing medical device startup is seeking a Quality Engineer to support the execution of its quality and regulatory strategy as the company advances from pivotal-stage development into FDA submission. This is a full-time, on-site role based in Roswell, Georgia.

The successful candidate will join a small but experienced cross-functional team committed to building innovative technologies that address critical unmet needs in healthcare. This role is highly execution-focused and ideal for professionals who are detail-oriented, adaptable, and motivated by the opportunity to contribute meaningfully in a dynamic, fast-paced environment.

This role offers a unique opportunity to make a significant impact during a critical growth stage of the company. The company is committed to building a high-performing team and fostering a collaborative and respectful work environment.

Key Responsibilities:

• Support quality engineering and assurance activities throughout the product lifecycle, including design control, risk management, and design transfer
• Maintain and manage documentation related to DMR, DHR, DHF, and Risk Management Files in alignment with FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019 requirements
• Collaborate closely with R&D, Regulatory, and Clinical teams to ensure quality and compliance objectives are met
• Assist in regulatory preparation for De Novo and potential 510(k) submissions
• Contribute to the continuous improvement of quality systems and processes to support scalability

Requirements:

• 3–5 years of quality engineering experience within the medical device industry (Class II or higher preferred)
• Working knowledge of relevant regulatory standards, including FDA, ISO 13485, ISO 14971, and EU MDR
• Experience with risk analysis tools, design control documentation, and electronic document management systems (eDMS)
• Strong communication skills with the ability to operate independently and escalate issues appropriately
• Proactive individual, collaborative, and committed to delivering high-quality work
• A team player who thrives in a startup environment and aligns with the company’s mission and values
• Candidates who are hands-on and execution-driven and used to working in a small team

Why Join:

• Work alongside experienced leadership with a strong track record in successful FDA submissions.
• Contribute to the development of cutting-edge medical technologies
• Be part of a values-driven organization that prioritizes culture, transparency, and accountability

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