Quality Engineer - Miami Lakes, United States - ATR International

ATR International Miami Lakes, United States

3 weeks ago

Description

Job Description

In this exciting role as a Quality Engineer, you will develop, modify, apply, and maintain quality standards and protocols for post-market analysis.

· Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

· Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.

· May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality

· Completes comprehensive review of HVAD log files to determine correlation between the reported event and electro-mechanic components.

· Reviews HVAD system testing results including but not limited to: profilometer measurements, front/back impeller pre-loads, axial gap measurements, in-vitro wet-test functional parameters, and stators conductivity results to determine a most probable root cause associated with a reported event.

· Determines potential interaction between reported event and all HVAD system components controller, batteries, pump, monitor, AC adapter, batterie charger, and surgical tools.

· Generates comprehensive HVAD product investigation reports to support findings, root cause, regulatory requirements and obtains the necessary release approvals.

· Creates and develops engineering projects for improvements of analysis/investigation process to eliminate process waste and reduce rework rates.

· Participates and/or conducts validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.

The ideal candidate will possess the following qualifications:

1. Medical device experience

2. Complaint handling experience preferred

3. Product Risk Management experience/Post market quality experience preferred

Education Required: Bachelor's/Master's in Biomedical/ Mechanical/Electrical Engineering

Years' Experience Required: 1-5

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