Artann Laboratories

TRA Electronic Systems

Temperature Controller

Bone Ultrasonometry

Colonoscopy Force Monitor

Mechanical Imaging

Breast Mechanical Imaging

Prostate Mechanical Imaging

Vaginal Tactile Imager

Shear Wave Elasticity Imaging

Temperature Profile Spectroscopy

Droplet MicroChromatography

Body Hydratation Monitor

TRA-Based Ultrasound Focusing

Job Opportunities

Position: Quality Engineer

Artann Laboratories, Inc. www.artannlabs.com is a growing research and development company with the mission of advancement and validation of innovative medical technologies and devices. With the support of over 30 grant and contract awards from various institutes of the National Institutes of Health, NASA and Department of Defense, Artann has developed numerous technologies in the diverse fields of medical diagnostics, biosensors and biotechnology, nondestructive testing, various technologies for industrial, aerospace and military applications. We’re looking for team players with a can-do attitude to share in our vision and enable progress on our projects. Artann offers competitive salaries,a comprehensive benefits package and a stimulating work environment.
We are seeking a Quality Engineer for our Trenton/Princeton, NJ facility.

Responsibilities:

Provide Quality Engineering support for engineering project development.
Develop, apply and maintain quality standards and protocols.
Develop quality documentation and control of medical device(s) manufacturing, validation, inspection and quality/regulatory compliance operating procedures to meet FDA, CE and ISO requirements.
Provide quality project management support as needed for product transfers from development to production.
Provide Quality Engineering support for manufacturing.
Review document and procedure changes for quality requirements and compliance with the quality system.
Develop quality systems and procedures as needed.

Qualifications:

BS degree in Engineering (Biomedical, Electrical, Mechanical).
At least 3 years’ experience in quality assurance in medical device industry.
Thorough knowledge of quality system regulations/requirements (ISO, FDA, CE, GMP, QSR).
Knowledge of medical device manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control).
Understanding of continuous improvement methodologies including Lean, Six Sigma and CAPA.
Strong understanding of documentation with medical device design specifications, verification, validation, and product release in the accordance with FDA requirements.
Demonstrated excellent written communication skills. Ability to write clearly in a variety of formats, such as procedures, processes, reports, applying correct English grammar and style.
Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, etc.).

Please submit your resume to artann@artannlabs.com.



		Overview Research Team Partnerships Breast Models Tissue Elastometer TRA Electronic Systems Temperature Controller Bone Ultrasonometry Colonoscopy Force Monitor Mechanical Imaging Breast Mechanical Imaging Prostate Mechanical Imaging Vaginal Tactile Imager Shear Wave Elasticity Imaging Temperature Profile Spectroscopy Droplet MicroChromatography Body Hydratation Monitor TRA-Based Ultrasound Focusing		Job Opportunities Position: Quality Engineer Artann Laboratories, Inc. www.artannlabs.com is a growing research and development company with the mission of advancement and validation of innovative medical technologies and devices. With the support of over 30 grant and contract awards from various institutes of the National Institutes of Health, NASA and Department of Defense, Artann has developed numerous technologies in the diverse fields of medical diagnostics, biosensors and biotechnology, nondestructive testing, various technologies for industrial, aerospace and military applications. We’re looking for team players with a can-do attitude to share in our vision and enable progress on our projects. Artann offers competitive salaries,a comprehensive benefits package and a stimulating work environment. We are seeking a Quality Engineer for our Trenton/Princeton, NJ facility. Responsibilities: Provide Quality Engineering support for engineering project development. Develop, apply and maintain quality standards and protocols. Develop quality documentation and control of medical device(s) manufacturing, validation, inspection and quality/regulatory compliance operating procedures to meet FDA, CE and ISO requirements. Provide quality project management support as needed for product transfers from development to production. Provide Quality Engineering support for manufacturing. Review document and procedure changes for quality requirements and compliance with the quality system. Develop quality systems and procedures as needed. Qualifications: BS degree in Engineering (Biomedical, Electrical, Mechanical). At least 3 years’ experience in quality assurance in medical device industry. Thorough knowledge of quality system regulations/requirements (ISO, FDA, CE, GMP, QSR). Knowledge of medical device manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control). Understanding of continuous improvement methodologies including Lean, Six Sigma and CAPA. Strong understanding of documentation with medical device design specifications, verification, validation, and product release in the accordance with FDA requirements. Demonstrated excellent written communication skills. Ability to write clearly in a variety of formats, such as procedures, processes, reports, applying correct English grammar and style. Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, etc.). Please submit your resume to artann@artannlabs.com.