- Edwards Lifesciences (Irvine, CA)
- …in collaboration with cross functional groups. + Collaborate with product manager , UX/UI designer, and software engineers on requirements, roadmaps, and execution ... + Experience with Software as a Medical Device (SaMD) and regulatory compliance ( FDA , ISO 13485, IEC 62304) + Familiarity with cybersecurity, data privacy (HIPAA),… more
- Medtronic (CO)
- …Ability to read and understand schematics and engineering drawings Familiar with the FDA 21 CFR, CGMP for Medical device Advanced education in Electrical Engineering ... interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the adherence of facilities, operations, studies, reports and practices to regulations (eg FDA , EMEA, NRC, DEA USDA) as well as to BIPI Standard Operating Procedures ... as a resource for colleagues with less experience; Assume the role of manager (when requested) **Requirements** + Bachelor's Degree or equivalent with 5 yr pharma… more
- F & S Fresh Foods (Riverside, CA)
- …action / preventive action) and follow up to Government (Federal - USDA / FDA / etc., State, County and City) inquiries. + Review documents and verify plant ... on projects. + Escalates difficult matters to the QA Supervisor or QA Manager as necessary. + Performs other duties as needed Requirements BASIC QUALIFICATIONS +… more
- Penn Medicine (Exton, PA)
- …protocol + Communicates with patients regarding patient flow and wait times - keeps manager aware of potential issues as they arise. + Issues referrals and obtains ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Change Management: + Flexible and readily… more
- Actalent (Deerfield, IL)
- …and external stakeholders. + Maintain compliance with safety and regulatory standards (OSHA, FDA , USDA, etc.). + Train and direct part-time team members on SOPs and ... Strong statistical analysis skills for sensory methodologies. + ServeSafe Manager Certification preferred. + Excellent communication, organization, and problem-solving… more
- Actalent (Summit Argo, IL)
- Job Title: Food Safety Specialist Job Description Support the Plant Quality Manager in managing, maintaining, and implementing Quality and Food Safety policies, ... beverage industry in QA/Food Safety/SQF Practitioner roles. + PCQI Certification. + Knowledge of FDA & GFSI (SQF, BRC, or FSSC) food safety and quality standards. +… more
- Actalent (Hercules, CA)
- …testing, sample management, and laboratory maintenance. Reporting to the Manager of Microbiology, this position involves working collaboratively to achieve ... with relevant experience in microbiology. + 2+ years of GMP/GLP laboratory/ FDA experience. Additional Skills & Qualifications + BS/BA in Biology, Pharmaceutical… more
- Actalent (St. Louis, MO)
- …finished production. + Place non-conforming product on hold for disposition by the QC Manager . + Pull product retain samples. + Comply with all company policies and ... Perform other duties as assigned. Essential Skills + Experience with GMP and FDA standards. + Proficiency in quality inspection and assurance. + Knowledge of… more
- University of Pennsylvania (Philadelphia, PA)
- …(PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs). The CRC ... final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log.… more