Responsibilities. Research and test the design, functionality and maintenance of products, equipment, systems, and processes and develop quality standards. Ability to read and interpret blueprints and evaluate product integrity and standards. Typically has a bachelor's degree in an engineering discipline. The technical skills include the ability to make sketches and engineering drawings and experience using computer applications related to the en...
Responsibilities. Job Description. Design electrical and/or power electronics circuitry for Premium CT Hardware either on NPI products or maintenance of installed base. Drives and is accountable for operational excellence of assigned designs, projects and rigor, with duties including design, project reviews, feasibility analysis, cost benefit analysis, prioritization, resourcing, initiation, execution and closure. Drive the development of prototy...
Job Description. In this Position of IT Quality Assurance Associate, you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements. Responsibilities. Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment. Lead and oversee the validation and qualification processes for GxP computerized systems ...
Company Description. Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description. Responsibilities. Research and test...
Job Description. The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PSQ functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and dri...
Purpose Statement. The APS team is an industry leading organization, providing unparalleled patient support that results in improved brand loyalty and patient satisfaction. The APS Operation team is seeking a Project Manager to partner with key stakeholders, drive project execution, and create new ways to improve APS Operations. Responsibilities. Provide ad-hoc support to individual teams to enhance productivity and address immediate project need...
Job Description. The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PSQ functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and dri...
Responsibilities. Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD). Provides primary programming and QC support for any internally produced outputs. Reviews and approves SAS programming instructions and C...
Responsibilities. Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems. Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies). Review and (remote) execute Computer System Validation protocols to ensure compli...
Roles & Responsibilities. Bachelor's degree in engineering required. 2-4 Years' Experience Required. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities. May write training material and conduct training session...
Responsibilities. Demonstrate an understanding and functional impact of changes to critical dimensions of components. Lead non-conformance containment, remedial action, and root cause investigation. Participate in disposition of non-conformances, track and trend in UAI, rework and scrap. On a limited basis, must have the ability to process, and where appropriate, investigate routine Medical Device customer feedback (complaints) in a high paced, e...
Responsibilities. Demonstrate an understanding and functional impact of changes to critical dimensions of components. Lead non-conformance containment, remedial action, and root cause investigation. Participate in disposition of non-conformances, track and trend in UAI, rework and scrap. On a limited basis, must have the ability to process, and where appropriate, investigate routine Medical Device customer feedback (complaints) in a high paced, e...
