Quality Assurance Engineer (ISO 13485)
PRISMATIK DENTALCRAFT, INC.
Summary
We're looking for a Quality Assurance Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex quality challenges, support new products and processes, and help ensure what we build meets the highest standards for safety, performance, and compliance.
Job description
Essential Functions
- Conducts engineering activities in compliance with FDA Regulations, ISO 13485, and other national and international quality and regulatory requirements and standards.
- Leads product quality assurance and quality engineering activities to drive strong engineering and technical knowledge.
- Creates quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements.
- Collaborates on investigations of NCR’s and complaints as necessary; suggests corrective and preventive actions based on engineering analysis and review; suggests effective solutions to drive continuous and measurable improvements.
- Works with various departments to ensure highest quality products and processes are developed, deployed, and meet all engineering requirements; activities include but not limited to product design testing, process testing, characterization, qualification, validation, and risk analysis/FMEA.
- Collaborates to create systems for the identification, analysis, correction, and prevention of quality issues; identifies areas for improvement as needed.
- Participates in quality engineering projects from inception to deployment.
- Participates in CAPA Management and other quality engineering projects.
- Participates in trainings for quality engineering tools within the organization using ISO 14971.
- Collaborates with team members to provide technicians and R&D personnel to provide technical leadership in problem resolution, process streamlining, and continuous improvement activities.
- Analyzes data and trends; reports results to management.
- Collaborates with team members to complete failure investigations and root cause analysis.
- Collaborates in design verification testing for design control projects.
- Performs returned product analysis and failure investigation activities.
- Ensures procedures and regulations are adequately followed during NCMR process.
- Ensures calibration and preventive management systems meet compliance requirements.
- Identifies the optimization of complex manufacturing processes using engineering methods for manufacturing design and continuous process improvement.
- Identifies opportunities for re-design and/or design of more complex equipment, tools, and fixtures to improve manufacturing processes and reduce risk.
- Performs other related duties and projects as business needs require at direction of management
Minimum Qualifications
- Bachelor’s degree in Science, Engineering, or related field; or equivalent combination of experience and training; advanced degree preferred
- Minimum three (3) years of experience in quality engineering and risk management.
- Knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
- Knowledge of risk management (ISO 14971), design controls, and validation methodologies.
- Proven analytical, problem-solving, and communication skills.
- Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
- Experience with combination products or Class I/II medical devices, preferred.
- Familiarity with EU MDR and UDI regulatory requirements, preferred.
Requirements
- Bachelor’s degree in Science, Engineering, or related field; or equivalent combination of experience and training; advanced degree preferred
- Minimum three (3) years of experience in quality engineering and risk management.
- Knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
- Knowledge of risk management (ISO 14971), design controls, and validation methodologies.
- Proven analytical, problem-solving, and communication skills.
- Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
- Experience with combination products or Class I/II medical devices, preferred.
- Familiarity with EU MDR and UDI regulatory requirements, preferred.
Company overview
Prismatik Dentalcraft, Inc. is a medical device company specializing in the design, development, and manufacturing of custom intraoral dental sleep medicine appliances. Headquartered in Newport Beach, California, with operations in Irvine, the company is a wholly owned subsidiary of Glidewell Dental, one of the largest dental laboratory organizations in the world. Founded in 2005, Prismatik Dentalcraft focuses primarily on creating mandibular advancement devices (MADs) for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA). Its flagship product line includes the Silent Nite® Sleep Appliance and the Silent Nite® Sleep Appliance with Glidewell Hinge™, both of which are FDA-cleared Class II medical devices. These custom-fabricated oral appliances work by gently repositioning the lower jaw forward during sleep to maintain an open airway, offering patients a comfortable and non-invasive alternative to CPAP therapy. The company serves dental professionals across the United States, providing prescription-based, patient-specific appliances manufactured using biocompatible materials and advanced thermoforming techniques. Prismatik Dentalcraft employs between 500 and 1,000 people and operates under rigorous quality management and regulatory compliance standards.