Quality Engineer

Vantedge Medical • Rancho Cordova, CA

2d • $88 - $96

About The Position

The Quality Engineer will provide support for product/process quality activities within Vantedge Medical. Areas of assignment may include: Product/Process improvement efforts, equipment validations, supplier quality performance and quality systems support.

Requirements

• 4-year degree in Quality/Mechanical/Industrial engineering or a closely related field.
• A minimum of 2 years of work experience in a related field in a medical device or manufacturing environment.
• Understand in depth quality systems, ISO 13485 and/or 9001 standards.
• Ability to create, review, and revise operating procedures, work instructions in English.
• Specific training and demonstrated success in applying quality problem solving method, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
• Minitab, JMP or other statistical software capabilities.

Responsibilities

• Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
• Work with suppliers and Supply Chain department to improve overall performance.
• Maintain metrics to evaluate process performance and work with manufacturing to ensure that expectations are met.
• Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R etc.).
• Assist the Director of Quality in maintaining ISO 13485 QMS.
• Create/Update work instructions and procedures as needed.
• Lead and/or create equipment validation protocols and reports.
• Undertake additional responsibilities or activities as required by Director of Quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level