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3 months ago
Salary band: $10k - $15k
Location: North America, United States, California
Job type: Permanent
Contact: Cameron Craig
Category: Quality Engineer
Quality Engineer - Medical Devices

Global, industry leading medical devices company seeks a Quality
Engineer to work on a new product development team. The Quality
Engineer will support a new Class III cardiac platform, focusing on
design control, design verification, design validation, failure
analysis, FMEA, quality control, process control, inspection and test
methodologies. The Quality Engineer will:

* Review and approve design changes, partner with R&D in the design
process
* Work with manufacturing engineers to develop new manufacturing
processes, providing quality support for pilot production of
new devices
* Run root cause analysis investigation for component and device
non-conformances
* Work with suppliers to manage quality issues with outside sources
* Provide quality support for design qualifications, design
transfer, regulatory submissions, development and implementation of
design control documents, presentations for design reviews, and
approval of product or process changes


Requirements:

* A bachelors degree in mechanical engineering, biomedical
engineering or related discipline
* 5+ years' experience in medical device manufacturing with
significant experience in quality engineering
* Quality engineering experience in medical device new product
development preferred
* Working knowledge of equipment qualification and design
verification in the medical device industry IQ OQ PQ
* A strack record of accomplishment in working effectively on cross
functional teams and as an independent contributor
* Strong results oriented communication skills; oral, written,
analytical and electronic
* Srong documentation skills
* Experience and the ability to produce strong hands-on work
* The ability to manage multiple competing priorities in a fast
paced environment

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