Summary: Provides technical and quality system guidance related to establishing product software as a medical device requirements. Provide quality oversight for product software as a medical device verification and validation activities ...
Roles & Responsibilities: Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues. Support pressurization challenge studies and evaluate what happens during loss of differential pre...
Summary The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quali...
Responsibilities: Responsible for the manual inspection, labeling, and packaging of clinical and commercial products. Perform finished product packaging as required to satisfy all customers, internal, clinical, and other demands. Ensure ...
execution. Worked in LifeSciences vertical both GxP and non GxP space. Familiar with Life science business process flow... with hands on testing deliverables. 5 years Hands On - POMS MES and Integration in LifeSciences. 2 years LifeSciences...
Responsibilities: Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA ...
Summary We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualificatio...
Responsibilities: Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals. Oversee engineering activities for projects including but not...
Summary : The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Qu...
deadlines. Preferred Qualifications: Bachelor's degree in Engineering, LifeSciences, or a related field. Experience... equipment in a GMP pharmaceutical environment. Solid understanding of Validation Life Cycle documentation, including risk...