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Vantedge Medical ยท 4 days ago
Quality Engineer
San Jose, CA
Full-time
Onsite
Entry, Mid Level
$73K/yr - $120K/yr
2+ years exp
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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 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.
Qualification
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Required
4-year degree in Quality/Mechanical/Industrial engineering or a closely related field.
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 methods, such as fishbone diagrams, 5 why, FMEA, process capability analysis, hypothesis testing, DoE, SPC, etc.
Minitab, JMP or other statistical software capabilities.
Company
Vantedge Medical
Vantedge Medical is a proven partner to Medical Technology OEMs.
1,001-5,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
