Senior Medical Device QA Engineer — Onsite in Irvine

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 99,000 - 120,000; Full time

Job summary

Prismatik Dentalcraft is a division of Glidewell Dental seeking a Sr. QA Engineer to embed quality into every stage of medical device development and manufacturing.

You will own quality engineering, risk management, CAPA, validation, and QMS, collaborating with R&D, Manufacturing, and Regulatory affairs to ensure safety, performance, and compliance. This onsite, Irvine-based role requires strong FDA/ISO knowledge, audits leadership, NCR investigations, and delivering robust corrective actions.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• Minimum 5 years in Quality Assurance or Quality Engineering in medical devices.
• Strong knowledge of FDA regulations, ISO 13485, and other applicable standards.
• Experience with ISO 14971 risk management, design controls, and validation methodologies.
• Certified Quality Engineer (CQE) or CQA preferred.

Responsibilities

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
• Lead CAPA investigations, non-conformance management, and root cause analysis (8D, Fishbone, 5 Whys).
• Own and improve elements of the QMS, including document control, internal audits, supplier quality, and change control.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs on design control and risk management.
• Lead internal and supplier audits; support external inspections (FDA, Notified Bodies).
• Participate in validation activities (IQ/OQ/PQ) for processes, equipment, and software.
• Develop, monitor, and analyze quality metrics; drive CAPA effectiveness.
• Provide quality engineering support to QC on inspection methods, metrology, and measurement system capability.
• Investigate NCRs, complaints, and deviations; implement effective corrective/preventive actions.
• Mentor junior engineers and foster a culture of quality and compliance.
• Integrate ISO 14971 and IEC 62366 activities within Prismatik/ Glidewell processes.
• Ensure training and internal communications maintain QMS compliance.
• Coordinate pilot production, process validations, and risk analyses for new products.

Skills

Quality Assurance

Quality Engineering

Regulatory Compliance

CAPA

Risk Management

Root Cause Analysis

Design Controls

Project Management

Six Sigma

Statistical Analysis

Education

Bachelors Degree

Tools

Minitab

QMS

Job description

Prismatik Dentalcraft is a division of Glidewell Dental seeking a Sr. QA Engineer to embed quality into every stage of medical device development and manufacturing.

You will own quality engineering, risk management, CAPA, validation, and QMS, collaborating with R&D, Manufacturing, and Regulatory affairs to ensure safety, performance, and compliance. This onsite, Irvine-based role requires strong FDA/ISO knowledge, audits leadership, NCR investigations, and delivering robust corrective actions.