cGxPServe

Responsibilities Quality Engineer in the medical device industry focusing on complaint investigation and non-conformance analysis including root cause analysis and corrective actions. Requirements: Medical Device Industry experience. In-depth Complaint Investigation. Experience in No More...

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part) GAMP5 me More...

Job Description: The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment ensuring data integrity and compliance. This includes writing reviewing and executing validation documents in alignment with regu More...

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and interna More...

Responsibilities: Proactively investigating identifying and implementing best-in-class quality engineering practices. Providing focused quality engineering support and assuming responsibility for timely and effective coordination and execution of assigned development project activiti More...

Job Description: As a problem solver you will tackle complex projects or unexpected challenges as opportunities to apply your considerable abilities. Whether working independently or in a team youll take on projects and find solutions. Your role is essential across various industries More...

Responsibilities: Support the Lead Data Manager across one or more clinical studies. Reviews protocols for appropriate data capture including electronic (eCRF) design. Support CRF design review and validation of clinical database. Provide expertise and support oversight of database s More...

Job Description: CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. This person will work More...

Responsibilities: Review protocols and comply with study-specific activities. Communicates in an appropriate and professional manner with study subjects and unit personnel. Maintain accurate and complete source data. Perform study protocol related activities i.e. phlebotomy sample pr More...

Responsibilities: Perform data manipulation analysis and reporting of clinical trial data. Develop and maintain department/system-level macros. Create and review SDTM and Adam specifications. Create and validate SDTM data sets. Create and validate analysis data sets. Create and valid More...

Roles & Responsibilities: Mechanical Engineering Biomedical Engineering Manufacturing Engineering. What are the 5 must-have skills for this position Experience in design changes and maintenance releases in medical device products. Hands-on mechanical design experience including build More...

Responsibilities: Validation Plan Development: Creating comprehensive validation plans that outline the steps for verifying equipment performance. Risk Assessment: Identifying and assessing potential risks associated with using the equipment. IOQ (Installation Qualification) OQ (Oper More...

Responsibilities: Your primary responsibilities will be to effectively organize and lead cross-functional project teams using your project management skills . Using your strong planning organization communication and collaboration skills you will lead a diverse scope of projects with More...

Responsibilities: Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates reviews and approves engineering changes. Acts as core team member providing review and analysis of appli More...

Job Description: We are looking for multiple CQV Engineers to support our LA area clients project. We are looking for CQV Engineers with CQV experience to provide execution support (IQ OQ PQ) for systems and equipment including process vessels buffer vessels filter presses centrifuge More...

Job Description: Seeking a hands-on Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs. This role focuses on ensuring the quality and integrity of new and existing products in accordance More...

Responsibilities: A minimum of 3 year of job-related experience; A bachelors degree (or equivalent experience) preferably in engineering. Engineering or manufacturing background plus familiarity with manufacturing processes used to produce components and assemblies for Caterpillar t More...

Job Description The Program Manager for the Meetings & Events (M&E) Centre of Excellence will lead the planning execution and oversight of Project Genesis across multiple OUS affiliates. The role involves coordinating with cross-functional teams to align project objectives managing st More...

Responsibilities: Leads all DM lifecycle activities from study start-up maintenance database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP) Case Report Forms (CRFs) CRF Completion Guidelines Edit Checks UAT specificatio More...

Job Description: Our client is seeking a Quality Engineer with experience in the medical device industry to support quality assurance and regulatory compliance efforts across product development and manufacturing. The ideal candidate will have a strong understanding of ISO 13485 FDA More...