DHR/QA Technician

The DHR/QA Technician plays a critical role in ensuring product quality and regulatory compliance through the execution of quality assurance activities. This position is responsible for interpreting and applying quality standards during routine manufacturing operations and final product release processes. The successful candidate will collaborate cross-functionally to uphold restor3d’s commitment to excellence and patient safety.

Key Responsibilities:

• Foster and maintain strong working relationships across internal teams to support collaborative quality efforts.
• Support the mission and objectives of the Sterility & Lot Release department by aligning daily work with departmental goals.
• Review and approve Device History Records (DHRs) to facilitate timely release of sub-assemblies and finished goods.
• Conduct thorough inspections of finished products, labels, and materials to ensure compliance with internal and regulatory standards.
• Verify labeling accuracy and precision in accordance with product specifications and documentation.
• Identify, document, and assist in the resolution of non-conforming materials or processes.
• Serve as the final quality assurance sign-off for product release.
• Adapt to evolving priorities and contribute to process improvement initiatives.
• Perform additional duties and responsibilities as assigned.

Qualifications & Experience:

• Exceptional written and verbal communication skills.
• Strong attention to detail with the ability to work effectively in a dynamic, fast-paced environment.
• Proven ability to ensure accuracy, quality, and completeness in documentation and inspection activities.
• Excellent organizational and time management skills, with the ability to prioritize multiple tasks effectively.
• Self-motivated, with the ability to work independently as well as collaboratively within a team setting.
• Prior experience working in a regulated environment; knowledge of FDA and ISO standards for medical devices is highly desirable.
• Demonstrated capability to troubleshoot and resolve quality-related issues with minimal supervision.
• Proficient in multitasking and maintaining a high level of productivity and accuracy under pressure.