Quality Systems Engineer II – Med Device Process Innovator

Confidential; Irvine (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Confidential in Irvine, CA seeks a Quality Engineer II to support the quality system, coordinating NCMRs and CAPAs, auditing, and ensuring document control and training compliance for neurovascular medical devices.

The role collaborates with multiple functions under the QS Supervisor, focusing on continuous improvement, FDA QMSR/ISO 13485, and applying statistics to process analysis and improvement.

Qualifications

• Bachelor's degree in an engineering or science discipline.
• 1+ years as an engineer in a related field.
• Medical device or pharmaceutical experience.
• Data analysis skills.

Responsibilities

• Knowledge of quality systems for medical device manufacturing and requirements for manufacturing, inspection, and testing
• Plans and documents (protocol and reporting) product/process validations
• Participates in audit activities
• Initiates and/or verifies corrective and preventive actions resulting from NCMRs, CAPAs, audit findings, and customer complaints
• May help with qualifications for manufacturing transfer activities, including new or changed materials and processes, and equipment IQ/OQ/PQ/PPQ
• Identifies, evaluates, and supports software validation activities
• Leads meetings for process improvement and problem solving
• Communicates with process stakeholders to address quality concerns and resolve issues
• Mantains and develops processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls
• Has a clear understanding of FDA's QMSR, ISO 13485 requirements, and EU medical device regulation, along with a good understanding of the application of statistics to process analysis and improvement

Skills

Data analysis

Quality systems knowledge

Cross-functional teamwork

Technical writing

Problem solving

Education

Bachelor's degree in engineering/science

Tools

Microsoft Project

Excel

Word

PowerPoint

Visio

Windows OS

Job description

Confidential in Irvine, CA seeks a Quality Engineer II to support the quality system, coordinating NCMRs and CAPAs, auditing, and ensuring document control and training compliance for neurovascular medical devices.

The role collaborates with multiple functions under the QS Supervisor, focusing on continuous improvement, FDA QMSR/ISO 13485, and applying statistics to process analysis and improvement.