- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more
- Penn Medicine (Bala Cynwyd, PA)
- …information.Other/ Regulatory :-Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, ... care agency through maintaining a patient/customer focus, supporting the delivery of high quality care, sharing a passion for patient and customer centered care, and… more
- Charles River Laboratories (Horsham, PA)
- …pertinent information. * Review documentation of functions performed as part of quality control requirements. * Retrieve and view Standard Operating Procedures using ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Lockheed Martin (King Of Prussia, PA)
- …for chemical processing systems, ensuring efficiency, safety, and compliance with regulatory standards\. * Collaborate with cross\-functional teams to review and ... deviations, and optimize production workflows to meet program deliverables and quality standards\. * Communicate with production personnel to implement process… more
- Teva Pharmaceuticals (West Chester, PA)
- …or engineering PREFERRED QUALIFICATIONS: + Knowledge of validation and quality compliance (cGMP/ICH/ FDA /USP/EP policies/guidelines) + Validation experience with ... Technically independent and maintains up-to-date knowledge of Validation standards and regulatory compliance requirements + Work with subject matter experts to… more
- BioLife Plasma Services (Harrisburg, PA)
- …and build your skills by contributing to financial, marketing, administrative, regulatory , quality , people, and facilities management. + **Contribute to ... Creating Life-Changing Medicines:** Maintaining our exceptional quality and service standards is key to creating life-changing...Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment… more
- Cook Medical (Pittsburgh, PA)
- …methodology associated with manufacturing a cell therapy product in an FDA -regulated environment.* Experience in Quality Assurance and/or Compliance functions ... system* Knowledge of metrics creation and data analysis* Knowledge of quality risk management guideline (Q9)* Experience in employee development* Experience with… more
- GE HealthCare (State College, PA)
- …MES and eDHR systems to align with production workflows. + Ensure compliance with regulatory standards (eg, FDA , ISO) in system usage and documentation. + ... workflows, and user procedures. + Coordinate with cross-functional teams including Quality , Engineering, IT, and Manufacturing. + Analyze production processes and… more
- Teleflex (Wayne, PA)
- …internal resources. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...Regulations, and all other international regulatory requirements with which NeoTract complies. TRAVEL REQUIRED: 35-50%… more
- Charles River Laboratories (Horsham, PA)
- …various types of studies. You will prepare and review documentation and perform quality control review of study data. You will contribute to department operations ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more