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4 days ago
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Quality Engineer - Medical Devices


Salary band: $10k - $15k
Location: North America, United States, Utah, Salt Lake City
Job type: Permanent
Contact: Cameron Craig
Category: Quality Engineer
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Quality Engineer - Medical Devices

Global medical devices leader seeks a Quality Engineer to lead quality
initiatives at the companys flagship manufacturing site in the
beautiful Salt Lake Valley area of Utah. This highly regarded
company offers excellent career growth opportunities across its many
divisions, domestic and international. The Quality Engineer will:


* Develop and execute tests and experiments on medical device
products in a manufacturing environment
* Optimize processes and manage continuous process
improvement using Lean and Six Sigma methodology, Design for
Manufacturing
* Lead quality teams to identify opportunities for re-design
or design of equipment, tools, and fixtures to improve
manufacturing processes, and reduce risk and scrap
* Using CAPA, non-conformances, root cause analysis, audit process
to resolve manufacturing and compliance issues.
* Resolve complex customer complaints and field performance issues
utilizing problem solving tools
* Write protocols, manufacturing instruction, tests, ensuring
specifications will produce results that meet end user needs;
* Recommend process changes based on detailed quality analysis and
studies

Requirements:

* Bachelors degree in engineering or scientific discipline
* A Bachelors degree in sciences or engineering is required
* 5+ years experience. This MUST INCLUDE QUALITY ASSURANCE in a
medical device environment but also could include internships and
relevant academic project work
* Validation and Verification experience
* Audit experience
* Experience with product transfers and manufacturing transfers is
preferred
* LEAN, Six Sigma experience may be preferred
* Experience within a product development preferred
* Working knowledge of ISO 13485, ISO 14971 and Total Quality
Management - TQM
* Excellent organizational skills, strong statistical skills, and
the ability to manage multiple competing priorities required.
* The ability to work well independently and as team member
* Strong communication skills; oral, written and electronic
Quality Engineer - Medical Devices

Global medical devices leader seeks a Quality Engineer to lead quality
initiatives at the companys flagship manufacturing site in the
beautiful Salt Lake Valley area of Utah. This highly regarded
company offers excellent career growth opportunities across its many
divisions, domestic and international. The Quality Engineer will:


* Develop and execute tests and experiments on medical device
products in a manufacturing environment
* Optimize processes and manage continuous process
improvement using Lean and Six Sigma methodology, Design for
Manufacturing
* Lead quality teams to identify opportunities for re-design
or design of equipment, tools, and fixtures to improve
manufacturing processes, and reduce risk and scrap
* Using CAPA, non-conformances, root cause analysis, audit process
to resolve manufacturing and compliance issues.
* Resolve complex customer complaints and field performance issues
utilizing problem solving tools
* Write protocols, manufacturing instruction, tests, ensuring
specifications will produce results that meet end user needs;
* Recommend process changes based on detailed quality analysis and
studies

Requirements:

* Bachelors degree in engineering or scientific discipline
* A Bachelors degree in sciences or engineering is required
* 5+ years experience. This MUST INCLUDE QUALITY ASSURANCE in a
medical device environment but also could include internships and
relevant academic project work
* Validation and Verification experience
* Audit experience
* Experience with product transfers and manufacturing transfers is
preferred
* LEAN, Six Sigma experience may be preferred
* Experience within a product development preferred
* Working knowledge of ISO 13485, ISO 14971 and Total Quality
Management - TQM
* Excellent organizational skills, strong statistical skills, and
the ability to manage multiple competing priorities required.
* The ability to work well independently and as team member
* Strong communication skills; oral, written and electronic

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