Quality Assurance Engineer

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POST DATE 8/10/2016
END DATE 10/12/2016


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Job Classification
Full Time
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Provide Quality Engineering support to design and
development of new products and the Quality System to
ensure delivery of the highest quality product to the
Duties & Responsibilities
* Drives effective quality assurance initiatives to
achieve Quality System compliance, product quality
and reliability with focus on design
* Drive and support functional owners to achieve
effective use of risk management processes through
the use of FMEA, and mistake proofing in product,
and process design
* Drive and support functional owners to achieve
effective design verification and validation results
to meet regulatory requirements
* Drive and support functional owners to achieve
effective use of technical and formal design reviews
for product designs
* Drives or conducts failure analysis to root cause
and institutes corrective and preventive actions for
quality processes across the work site
* Educates employees and ensures effective use of
Quality Tools such as Fishbone diagram, 5 whys,
PDCA, data collection and Pareto analysis, 8D
problem solving, Mistake Proofing, FMEA, etc.
* Manages the quality of incoming parts for
* Develops, implements, and maintains Quality and
Regulatory Affairs Plans
* Supports external audits and conducts internal
audits to ensure full compliance to required ISO
13485 and FDA 21CFR820 requirements.
* Maintain the site Quality Management System
* Bachelor Degree in Engineering (Mechanical,
Industrial or Electrical preferred), quality
assurance or biomedical field required
* Minimum of 5 years of experience in quality
engineering/assurance required
* 3 years of experience in a FDA and ISO 13485 quality
assurance organization required
* Demonstrated ability to apply technical principles,
practices and procedures across the whole
organization to ensure regulatory compliance
* Deep knowledge in the creation, deployment and
support of Quality Systems, Processes and Tools
* Working knowledge in planning, coordinating and
supporting design transfer activities required
* Requires the ability to be hands on and multi task
* Must be able to provide clear and concise verbal and
written communication across a wide range of
audience, from senior management to engineers in R&D
Preferred qualifications:
* Expertise in medical device new product introduction
and design control, including software
* Design validation experience (hardware/software)
* Risk Management experience
* Internal Auditor experience
* SAP experience