Quality Engineer jobs in United States
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Apetan Consulting LLC · 3 hours ago

Quality Engineer

Apetan Consulting LLC is seeking a Quality Engineer to ensure that cell processes are correctly base-lined and controlled. The role involves supporting the Material Review Board for non-conformances, leading corrective actions, and improving quality systems to meet ISO 13485 and FDA requirements.

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Responsibilities

Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC
Supports the Material Review Board (MRB) for internal non-conformances and customer returns
May lead or verify effectiveness of corrective and preventive actions (CAPAs)
Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements
Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements

Qualification

GD&TBlueprint readingCAPARoot Cause AnalysisMed device experienceManufacturing experienceTight tolerance measurementISO standardsFDA quality systemBachelor’s DegreeShort-run process controlDOE

Required

Technical experience with GD&T
Knowledge of blueprint reading and ability to describe the symbols on a blueprint and what the symbols mean
CAPA
Root Cause Analysis
0-3 years' experience with tight tolerance measurement systems in machining applications
Working knowledge of short-run process control methods
DOE
ISO standards
FDA quality system regulation

Preferred

Bachelor's Degree in Engineering or related field
Med device and Manufacturing experience

Company

Apetan Consulting LLC

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We are a prominent executive search & selection company, providing a wide range of recruitment solutions for various requirements.

Funding

Current Stage
Growth Stage
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