Quality System Engineer

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

The Quality System Quality Engineer II will be responsible for supporting the company's quality system, including but not limited to coordination of NCMRs and CAPAs, supporting audit execution, and supporting document control and training compliance.

This Quality Engineer will work directly with different functions while receiving support and guidance from other engineering staff and the QS Supervisor to complete tasks. This position will have the responsibility to support and continuously improve current QS processes through technical and process innovation for the manufacture of neurovascular medical devices.

Job 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
• Maintains 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

Qualification Requirements

• Bachelor's degree required, preferably in an engineering or science discipline
• 1+ years as an engineer in a related field
• Medical device or pharmaceutical experience
• Data analysis skill set

Highly Desired Qualifications

• Class II and III implantable medical device experience, with a focus on neurovascular devices
• Strong communication skills working with multiple departments
• Demonstrated ability to plan and run projects

Skills

• Keen attention to detail when reviewing documentation and processes
• Solid technical writing ability
• Able to work independently and cross-functionally as part of a team
• Comfortable communicating with a wide range of people from production, regulatory, management, suppliers, and other functions
• General understanding of risk management, including design, use, and process FMEAs, as well as a basic understanding of severity, occurrence, and risk mitigation and their impact on product and process controls
• General understanding of process validation (OQ/PQ) and ability to develop test protocols/reports to meet FDA and ISO requirements for Class II and Class III devices
• Understanding of the CAPA process and root cause analysis tools and how to use them
• Ability to develop manufacturing documentation (e.g., manufacturing procedures, engineering drawings, BOM, work orders)
• General familiarity with design control requirements and V&V testing for new product designs
• Effectiveness with lab equipment, assembly tools, and measurement devices
• Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing
• Knowledge of computer applications (e.g., Microsoft Project, Word, Excel, PowerPoint, Windows, Visio) required
• Working conditions are normal for an office environment
• Extended computer usage
• Standard PPE gowning requirement for cleanroom activities is required