PRISMATIK DENTALCRAFT, INC. · 5 hours ago
Sr. Quality Assurance Engineer (ISO 13485)
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $130K/yr
5+ years expPrismatik Dentalcraft, a division of Glidewell Dental, is seeking a Sr. Quality Assurance Engineer to ensure compliance with regulatory standards in the medical device industry. The role involves leading quality management initiatives, conducting audits, and collaborating cross-functionally to support product development and continuous improvement efforts.
Medical Device
Responsibilities
Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR
Lead and support CAPA investigations, non-conformance management, and root cause analysis using tools such as 8D, Fishbone, and 5 Whys
Own and continuously improve elements of the Quality Management System (QMS), including document control, internal audits, supplier quality, and change control
Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support design control, risk management (ISO 14971), and product development lifecycle activities
Lead internal and supplier audits, and support external audits and inspections (e.g., FDA, Notified Bodies)
Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software used in manufacturing and quality operations
Develop, monitor, and analyze quality metrics to identify trends, drive continuous improvement, and ensure effectiveness of corrective actions
Provide quality engineering support to Quality Control, including guidance on inspection methods, metrology, and measurement system capability
Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable corrective and preventive actions based on engineering analysis
Lead and mentor junior engineers, fostering technical growth and reinforcing a culture of quality and compliance
Integrate ISO 14971 risk management and IEC 62366 usability engineering activities within Glidewell/Prismatik processes
Ensure organizational compliance with the QMS through ongoing training, education, and internal communication
Collaborate with Manufacturing and Engineering to coordinate pilot production, process validations, and risk analyses for new products and processes
Ensure calibration and preventive maintenance systems meet compliance and operational requirements
Identify and implement process optimizations using Lean and Six Sigma methodologies to improve manufacturability, reduce risk, and enhance efficiency
Identify opportunities for design or re-design of equipment, tools, and fixtures to improve manufacturing processes and product quality
Perform other related duties and special projects as assigned by management
Qualification
Required
Bachelor's degree in Engineering, Science, or a related technical field
Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry, or equivalent education and experience demonstrating comparable skills and knowledge
Strong working knowledge of FDA regulations, ISO 13485, and other applicable international quality standards
Hands-on experience with 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
Demonstrated project management experience
Preferred
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification
Experience with combination products or Class I/II medical devices
Familiarity with EU MDR and UDI regulatory requirements
Company
PRISMATIK DENTALCRAFT, INC.
PRISMATIK DENTALCRAFT, INC. is a Glidewell Dental company.
Founded in 2005Newport Beach, California, US
501-1000 employees
H1B Sponsorship
PRISMATIK DENTALCRAFT, INC. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase