Senior Quality Engineer

Dandy is transforming the massive and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world‑class support to achieve more for their practices, their people, and their patients.

Dandy is seeking a skilled and proactive Senior Quality Engineer to join our fast‑growing, venture‑backed team. The ideal candidate for this role is someone with strong technical depth in quality control excited to redefine industry best practices and find solutions to challenging new problems to help enable Dandy’s goals. The ideal candidate will have a strong continuous improvement background, insatiable curiosity, and a desire to learn and grow.

• Establish, refine, and document quality control standards, inspection methods, and testing protocols.
• Monitor the production process to ensure adherence to quality standards at every stage.
• Lead CAPA initiatives with external partners to determine root cause and ensure necessary actions to correct are implemented.
• Work with onsite Quality Manager to train and mentor production staff on quality practices and compliance requirements.
• Investigate and resolve production issues by analyzing root causes and implementing corrective actions.
• Collect, analyze, and summarize quality data to generate actionable insights and detailed reports.
• Act as a liaison for customer feedback, adapting processes to meet quality expectations and regulatory standards.
• Innovate on existing quality processes and work with software and automation engineering teams to build tooling that supports product quality.
• Support the ISO certification process and prepare the organization for ISO recertification audits.
• Partner with Manufacturing and Design teams to drive process quality improvements through application of SPC, capability analysis, and defect trend reviews.
• Conduct Measurement System Analysis (MSA) such as Gage R&R to ensure reliability of inspection and testing methods across critical quality checkpoints.

• Proven experience in a quality engineering or leadership role within a manufacturing environment.
• Must have hands‑on experience managing ISO 13485 quality management systems, including documentation, internal audits, and compliance activities.
• Demonstrated ability to lead teams through ISO certification and external audit processes, including gap assessments and CAPA closure.
• Experience in quality validation of new equipment and processes, including creation of validation protocols (IQ/OQ/PQ), risk assessments, and ensuring compliance with regulatory requirements.
• Strong problem‑solving skills with a data‑driven approach to root cause analysis, nonconformance management, and preventive action planning.
• Proficiency in statistical methods, process capability analysis, and using tools such as Minitab, Excel, or JMP.
• Familiarity with quality elements of design and manufacturing transfer, particularly in dental prosthetics or other Class I/II medical devices.
• Ability to interpret and apply regulatory and standard requirements (e.g., 21 CFR Part 820, ISO 13485:2016, MDSAP).
• Excellent communication, collaboration, and training skills with a track record of guiding cross‑functional teams.
• High attention to detail and the ability to operate effectively under fast‑paced, deadline‑driven conditions.
• Ability to independently manage quality projects and deliver compliant results with minimal supervision.

• Experience working in a fast‑paced startup environment, wearing multiple hats across quality, operations, and compliance.
• Direct involvement in New Product Introduction (NPI) or product launches, including design transfer, process validation, and first‑article quality reviews.
• Building or scaling quality systems from the ground up, especially in early‑stage or rapidly growing organizations.
• Demonstrated ability…