Job Summary: Ensure quality engineering activities for released products comply with regulatory and internal standards while supporting risk management, verification & validation, process validation, and sustaining engineering activities....
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Roles & Responsibilities: Develop quality assurance documentation for new product development and regulatory submissions. Maintain and improve quality system processes by identifying and correcting deficiencies. Engage in design, develo...
Summary : The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to...
Job Description: Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation). The RAS is responsible for...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Ensure quality engineering activities for released products comply with regulatory and internal standards. Collaborate with cross-functional teams to develop product risk management documentation, including Risk Management Plans, Risk Asse...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: Documents and analyses design requirements for implementation. RTL coding, simulating and implementation. Pin assignment based on hardware design. Keeps the HW/SW interface documents up to date. Develops interface an...
Job Description: The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensur...
Responsibilities: Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert...
Job Description: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs acti...
Roles & Responsibilities: Ensure quality engineering activities for released products comply with regulatory and internal standards. Collaborate with cross-functional teams to develop product risk management documentation, including Risk...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Job Description: The Quality Engineer I plays a key role in maintaining product quality, compliance, and process control for medical device manufacturing. This position ensures adherence to regulatory standards, drives continuous improveme...
Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f...
Roles & Responsibilities: Medical device experience, value engineering, verification, validation documentation. Project management. Experience in VAVE methodologies and tools. Knowledge of medical device development lifecycle and standa...
Responsibilities: Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the stu...
Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are. Must be able to pe...