Senior Quality Engineer

Fremont  ‐ Onsite
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Keywords

Description

Essential Functions:
Ensure that the products are of high quality, safe, and effective at all stages of product realization process through the implementation and maintenance of an effective manufacturing quality assurance and quality control system
Work with R&D on product development projects. Work with Manufacturing Engineering on product/process improvement projects. Works closely with software, mechanical, and electrical engineers to define system requirements
Investigate and analyze failures. Recommend and implement corrective and preventive measures as necessary
Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards.
Coordinate factory inspection by regulatory agencies certifying the products for electrical safety and EMC
Perform inspection and testing of the products as assigned
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Skill Requirements:
Previous experience in Quality Engineering in medical device industry is a must
Experienced in software controlled electrical and electro-mechanical devices is highly preferred. Exposure to sterile disposable products such catheters is preferred
Demonstrated experience/skill in risk analysis, failure analysis, and CAPA
In depth knowledge of Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods and Lean Manufacturing
Thorough knowledge of QSR and ISO ) requirements
Knowledge of UL and IEC standards for device compliance

Education/Training/Experience Requirements:
B.S. in Electrical Engineering or equivalent is required. Experience in the medical device industry in a Quality Engineering and or Test Engineering capacity is desired.
Minimum 3 years (Quality Engineer) or minimum 5-7 (Sr. Quality Engineer) or 7-10 years of experience in the medical device industry in a Quality Engineering capacity
Start date
07/2014
From
Real Staffing
Published at
10.07.2014
Project ID:
739454
Contract type
Freelance
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