Senior Quality Engineer at Dandy

Carrollton, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Dental, Technology, HealthcareIndustries

Requirements

Proven experience in a quality engineering or leadership role within a manufacturing environment
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
(Bonus) Experience working in a fast-paced startup environment, wearing multiple hats across quality, operations, and compliance
(Bonus) Direct involvement in New Product Introduction (NPI) or product launches

Responsibilities

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

Skills

Key technologies and capabilities for this role

Quality ControlCAPARoot Cause AnalysisContinuous ImprovementISO CertificationData AnalysisProduction MonitoringTraining and MentoringProcess InnovationAutomation Tooling

Questions & Answers

Common questions about this position

Is this position remote or onsite?

The position is onsite.

What salary or compensation does this role offer?

This information is not specified in the job description.

What key experiences are required for this Senior Quality Engineer role?

Candidates must have proven experience in a quality engineering or leadership role in manufacturing, hands-on experience managing ISO 13485 quality systems including audits and compliance, and experience leading ISO certification and external audits with CAPA closure.

What does Dandy's team and culture look like?

Dandy is a fast-growing, venture-backed team transforming the dental industry with technology and innovation.

What makes a strong candidate for this position?

A strong candidate has strong technical depth in quality control, a continuous improvement background, insatiable curiosity, a desire to learn and grow, plus hands-on ISO 13485 experience and problem-solving skills.

Dandy

Digital dental lab services and software

About Dandy

Dandy provides digital dentistry solutions to dental practices across the United States, enabling them to transition from traditional methods to modern digital techniques. Their services include digital scanning, design, and manufacturing of dental prosthetics such as dentures and implants. Dandy's proprietary Chairside software simplifies the scanning process, allowing dental professionals to perform complex procedures with greater accuracy and efficiency. Unlike competitors, Dandy offers their Chairside software for free, making it easier for practices to scan patients and submit lab cases. The company generates revenue through the manufacturing and sale of dental products based on these digital scans, along with providing clinical support and live scan feedback. Dandy's goal is to enhance patient experiences and improve operational efficiency for dental practices by facilitating the adoption of digital dentistry.

New York City, New YorkHeadquarters

2020Year Founded

$4.2MTotal Funding

SEEDCompany Stage

Enterprise Software, HealthcareIndustries

1,001-5,000Employees

Benefits

Medical, dental, & vision coverage

Parental planning

Mental health benefits

401(k) plan

PTO

Fitness reimbursements

Risks

Competition from established companies like Align Technology is increasing.

Data privacy concerns are rising with digitalization in the dental industry.

Rising raw material costs could impact Dandy's profit margins.

Differentiation

Dandy offers a unique end-to-end digital dental lab service.

Their Chairside software simplifies the scanning process for dental professionals.

Dandy provides free software, earning revenue from dental prosthetics sales.

Upsides

Growing demand for digital dental solutions aligns with Dandy's offerings.

Personalized dental care trend supports Dandy's customized prosthetics services.

AI integration in dental imaging complements Dandy's digital scanning technology.

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