- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + Work collaboratively with ... PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to...action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + Contribute to the ... strategic input on the conduct of MAPs to ensure compliance with PV requirements + Ensuring SP/vendor oversight under...of PV Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …on regulatory requirements to development teams. + Manage and execute pre-approval compliance activities. + Assess the acceptability of quality , preclinical and ... product development programs and overall business objectives, the Director assures compliance with applicable regulations for all pre-market and post-market product… more
- Olympus Corporation of the Americas (Westborough, MA)
- …working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, ... leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of… more
- Globus Medical, Inc. (West Carrollton, OH)
- …instructions to plan the finishing/assembly or re-work to be performed + Drives quality compliance by documenting results, and by using workmanship standards and ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...understanding of MS Office software + Perform duties in compliance with applicable FDA and state regulations… more
- Veterans Affairs, Veterans Health Administration (Providence, RI)
- …in the conduct of research and advises Research and Safety leadership, as needed. Quality and Compliance Develops and maintains a project pre-review program that ... community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden. This position is full-time at 40… more
- University of Michigan (Ann Arbor, MI)
- …service meal preparation and delivery for patients, supervising staff, and ensuring compliance with safety, quality , and regulatory standards. The ideal ... + Provide coaching and disciplinary action as needed. Safety, Compliance & Quality Assurance + Protect patient...promoting teamwork, and motivating staff + Knowledge of the FDA Food Code and experience managing kitchen operations using… more
- University of Colorado (Aurora, CO)
- …from research in an accurate and timely manner + Evaluate data sets for quality and completeness. Set up and or run statistical analyses. + Analyze data, including ... statistical analyses and qualitative assessments of data and data quality . Identify and help solve gaps in data collection. + Adhere to research regulatory standards… more
- Covenant Health Inc. (Knoxville, TN)
- …in administering protocol treatments. Supervising Clinical Research Associates. + Implements quality controls and assurance measures by monitoring compliance ... protection. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities,… more
- Fortrex (MN)
- …safety technologies, such as rapid microbial testing, blockchain traceability, and AI-powered quality control. . **Regulatory Compliance :** Ensure compliance ... in food safety and pathogen control. + Meticulous approach to safety standards, compliance , and quality , ensuring that all solutions meet the highest safety… more