Responsibilities and Requirements :
Education : Bachelor of Science in Engineering, / Mechanical Engg. / Mech. Engg. + years relevant experience in Medical Device Manufacturing.
Clean room environment experience Experience with Test Method Validation and / or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA Quality System Regulation ( CFR ) and ISO . Strong organizational skills, detail oriented.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint. Experience with D CAD Software SolidWorks Experience working with Engineering change management software & releasing engineering change orders.
Process and equipment qualification (IQ / OQ / PQ). Development of test methods for Design V&V, Process Validation, and Production Validation of test methods.
Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. Authoring / releasing of new test methods and editing / redlining of old test methods.
Experience working in a regulated and / or medical device environment. To define equipment requirements. To draft equipment specifications.
To work on change management and releasing engineering change orders To design process validations and identify critical process parameters related to equipment Working.
Quality/ Validation Engineer
Experience working with Engineering change management software & releasing engineering change orders. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. Education: Bachelor of Science in Engineering, B. Experience with Test Method Validation an...
Quality Systems Specialist/Administrator - Senior Validation Engineer 2 - 4961
The Quality Systems Specialist/Admin will be responsible for maintaining various quality and validation applications. IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system, validation lifecycle management system, electronic signature systems. Demons...
Quality/ Validation Engineer
Experience with D CAD Software SolidWorks Experience working with Engineering change management software & releasing engineering change orders. Development of test methods for Design V&V, Process Validation, and Production Validation of test methods. Execution of Engineering Builds, Gauge R&R Studie...
Quality Systems Specialist/Administrator - Senior Validation Engineer 2 - 4961
The Quality Systems Specialist/Admin will be responsible for maintaining various quality and validation applications. IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system, validation lifecycle management system, electronic signature systems. Demons...
Validation Engineer - Cloud Qualification
Job Title:Validation Engineer - Cloud QualificationJob Function:Validation AnalystLocation:Bridgewater, NJ. ...
Senior Software QA Analyst
A company is looking for a Senior Software QA Analyst. ...
Senior QA Analyst - Veeva CRM
Develop Test/Validation Master Plan and test strategies.Develop detailed Test/Validation scripts.Lead testers through aggressive test cycles.This includes leading the Business Testers and interacting with Development where required to complete the necessary work.Tracking and report on testing status...
Validation Engineer
The Equipment Validation Engineer supports the successful implementation of various process/lab. Develops validation/qualification deliverables such as Validation Plans, Requirements. BS in Engineering or Science related discipline required. Supports the execution of equipment qualifications and val...
QA Engineer
QA Engineer – Contract – Warren, NJ – $60. Our client is seeking a QA Engineer in Warren, NJ. The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment ...
Manufacturing Engineer
Lumicity is partnered with an exciting manufacturing company in New Jersey that is working on a wide range of projects in the medical, aerospace, and defense industries. You will play a critical role in creating and refining processes in order to improve manufacturing safety, quality, and productivi...