Quality Engineer – Medical Devices, Process & CAPA Leader

Vantedge Medical Company; Rancho Cordova, Northern (CA, KY); Hybrid; USD 90,000 - 115,000; Full time

Job summary

Vantedge Medical is seeking a Quality Engineer to support product and process quality activities across our medical device manufacturing operations. This onsite role focuses on CAPA, supplier quality, and process improvements to ensure sustained quality performance.

The ideal candidate has a 4-year engineering degree, 2+ years of medical device/manufacturing experience, and hands-on knowledge of quality tools and systems (ISO 13485/9001, DoE, SPC).

Qualifications

• 4-year degree in Quality/Mechanical/Industrial engineering or related field.
• Minimum 2 years of medical device/manufacturing experience.
• Understand ISO 13485 and/or 9001 quality systems.
• Ability to create, review and revise procedures in English.
• Demonstrated training in quality problem solving methods (fishbone, 5 Whys, FMEA, DoE, SPC).

Responsibilities

• Generate internal quality reports based on CAPA, complaints and yield. Propose and drive product/process improvement initiatives.
• Work with suppliers and Supply Chain 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.

Skills

Quality problem solving

Statistical analysis

Documentation

Education

Bachelor's degree in Quality/Mechanical/Industrial engineering

Tools

Minitab

JMP

Job description

Vantedge Medical is seeking a Quality Engineer to support product and process quality activities across our medical device manufacturing operations. This onsite role focuses on CAPA, supplier quality, and process improvements to ensure sustained quality performance.

The ideal candidate has a 4-year engineering degree, 2+ years of medical device/manufacturing experience, and hands-on knowledge of quality tools and systems (ISO 13485/9001, DoE, SPC).