and mentorship to junior staff or specialists on assigned projects. Requirements: Bachelor's degree in Regulatory Affairs, Life... Sciences, Engineering, or a related field. 4-6 years of regulatory affairs experience in the medical device or IVD industry...
Job Summary: We are seeking an experienced Supplier Quality Engineer to support supplier quality initiatives and material quality performance for a short-term, on-site contract role in Perrysburg, OH. The role involves working closely with...
Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection, operating equipment, raw material/finished goods movement ...
Roles & Responsibilities: Perform non-conformance (Client) investigations within the Track Wise 8 Management System. Execute implementation of CAPAs associated with Client investigations. Maintains a high level of expertise in current r...
Responsibilities : Supporting core Quality Systems activities (SOP revisions, inspection readiness, metrics). Developing and improving regional Quality System SOPs. Analyzing quality and risk metrics and escalating gaps as needed. Supp...
Responsibilities: This position IS NOT related to shipping OR shipment packaging. This is a manufacturing type position and involves filling of liquid antibodies into small vials in a laboratory environment and using lab instruments such...
Roles and responsibilities: Must-Have Skills & Experience. Strong experience in Large-Scale Equipment CQV. Mandatory IOQ experience with Filter Press or Centrifuge (one required). Hands-on execution of IQ, OQ, PQ for capital projects. ...
Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their conta...
-life, and transit testing. Prepare packaging verification and validation protocols and reports in compliance..., shelf-life, and transit testing. Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820. Experience with process...
Roles & Responsibilities: Process qualification and non-conformance investigations and work independently with limited guidance. Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, qualit...