Quality Assurance Engineer – Medical Devices, Onsite Irvine

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

PRISMATIK DENTALCRAFT, INC. is seeking a Quality Assurance Engineer to embed quality into medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS initiatives with cross-functional teams to ensure safety, performance, and regulatory compliance.

Required: Bachelor’s in a related field with at least 3 years in quality engineering, knowledge of FDA/ISO 13485, ISO 14971, and validation. Onsite role at Irvine, CA with no remote option.

Qualifications

• Bachelor’s degree in science/engineering or related field; advanced degree preferred.
• Minimum three years of quality engineering and risk management experience.
• Knowledge of FDA regulations, ISO 13485, and other quality standards.
• Familiarity with ISO 14971, design controls, and validation methodologies.
• Certifications like CQE, CQA, or Six Sigma are a plus.

Responsibilities

• Ensure compliance with FDA and ISO 13485 across design, development, and manufacturing.
• Lead QA/quality engineering activities to strengthen engineering knowledge.
• Develop QA programs to meet applicable regulatory requirements.
• Investigate NCRs and complaints; drive CAPA actions and corrective solutions.
• Collaborate on product and process testing, validation, and risk analysis.
• Identify and implement improvements to reduce quality risks and costs.
• Support design verification testing and failure investigations.
• Provide technical leadership to technicians and R&D staff.

Skills

Quality engineering

Risk management

Statistical analysis

Communication skills

Education

Bachelor's degree in Science, Engineering, or related field

Tools

Minitab

Job description

PRISMATIK DENTALCRAFT, INC. is seeking a Quality Assurance Engineer to embed quality into medical device development and manufacturing. You will own quality engineering, risk management, CAPA, validation, and QMS initiatives with cross-functional teams to ensure safety, performance, and regulatory compliance.

Required: Bachelor’s in a related field with at least 3 years in quality engineering, knowledge of FDA/ISO 13485, ISO 14971, and validation. Onsite role at Irvine, CA with no remote option.