- Actalent (Azusa, CA)
- …and Microsoft Office Suit Skills Quality assurance, cgmp, qms, audit, capa, change control, fda compliance , iso standards, spc, lean six sigma, iso 9001, sop, ... change management Top Skills Details Quality assurance,cgmp,qms,audit,capa,change control, fda compliance ,iso standards,spc Additional Skills & Qualifications… more
- Philips (Cambridge, MA)
- … compliance training initiatives. **You're the right fit if:** + 8+ years of FDA compliance experience, with at least 5 years as an attorney, focusing on ... particular to group functions (such as M&A, Finance, Q&R, Compliance , IT, Procurement, Research) and management and provides second...guidelines that are under the purview of the US FDA and other global medical device regulators. It will… more
- Philips (Colorado Springs, CO)
- …Quality system harmonization/simplification, the introduction/implementation of quality processes/tools, FDA /Notified body compliance and effective Management ... The Director of Quality & Compliance plays an important leadership role within Philips'...acquired a minimum of 12+ years' experience in global, FDA regulated medical device environments, including proven functional and… more
- Actalent (Carlsbad, CA)
- …up to date with industry trends and best practices. Skills Medical device, FDA Compliance , risk management, software quality management, design control, FDA ... diagnostic instruments, procedure writing, audit Top Skills Details Medical device, FDA Compliance ,risk management,software quality management,design control Additional… more
- Canon USA & Affiliates (CA)
- …Engineering Managers in pre-market submission preparation. + Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's ... + Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by...and procedures, as required. + Submit and track pending FDA submissions (510K's, PMAs), IDE, and IRB, as applicable.… more
- System One (Lakewood, CO)
- …Medical Device, ISO 13485, FDA QSR, CAPA, Supplier Development, FDA Compliance , Audits, Risk Management, Cross-Functional Collaboration, Root Cause Analysis. ... supplier quality programs, conducting audits, resolving issues, and ensuring compliance with ISO 13485 and FDA QSR....and ensuring compliance with ISO 13485 and FDA QSR. You will drive continuous improvement, support supplier… more
- Actalent (Hilliard, OH)
- …accurately. Essential Skills + Quality Control + Manufacturing + SOP adherence + FDA regulation compliance + Inspection + Documentation + Aseptic techniques + ... Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) within an FDA -regulated environment. Responsibilities + Follow SOPs, GMPs, and all FDA… more
- Mount Sinai Health System (New York, NY)
- …will be responsible for supporting the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local ... includes maintaining the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with… more
- J&J Family of Companies (Santa Clara, CA)
- …of sonic pressure waves for the treatment of calcified plaque. Position Overview In compliance with FDA , European MDD/MDR & ISO regulations, the Senior Quality ... Johnson & Johnson is hiring for a Senior Quality Compliance Specialist to join our Quality team located in...company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. **Qualifications** +… more
- University of Rochester (Rochester, NY)
- …Updates information on Federal Clinical Trials web site. - Responsible for FDA compliance , maintenance and progress reports for Investigational New Drug ... materials to participants and team members as appropriate. Ensures compliance and follows up and communicates as needed. Directs...- Develops and submits progress reports to RSRB and FDA as appropriate. - Supervises study visits to ensure… more
- Nestle (Bridgewater, NJ)
- …guidance, and communications plan to address new business initiatives and ensure compliance with FDA and federal healthcare program requirements, and all ... auditing and monitoring activities. + Manage transparency reporting, including compliance with US federal Sunshine Act, FDA ...including compliance with US federal Sunshine Act, FDA samples reporting, and state disclosure law reports. +… more
- ThermoFisher Scientific (Manati, PR)
- …+ Proven capability to perform management duties. + Knowledge of cGMP and FDA compliance . + Strong interpersonal and communication skills, leadership ability, ... the highest standards. This role is crucial for maintaining compliance with current Good Manufacturing Practices (cGMPs) and global...products. + Participate as an escort during regulatory audits ( FDA , DEA, MCA, Client, or Internal). + Examine and… more
- Bon Secours Mercy Health (Toledo, OH)
- …with the preparation for and participates in sponsor-related quality assurance audits and FDA compliance audits, as required. + Assists with the preparation of ... participants, maintaining research materials required for coordinating projects, protocol compliance , assisting research investigators in developing and completing research… more
- CBRE (Irvine, CA)
- …quality metrics to client leadership. + Manage quality projects to bring CBRE into compliance with FDA and client standards. + Leverage CBRE corporate & client ... Quality & Compliance Manager Job ID 206624 Posted 14-Feb-2025 Service...preferred. Previous supervisory experience a plus. **CERTIFICATES and/or LICENSES** FDA , ISO, or similar quality assurance audit related certification… more
- Stryker (Boston, MA)
- …standards and company policy. + Legal compliance including ISO standards and FDA compliance . + Drive and report field service metrics to defined goals. ... + Performance vs. objectives set forth annually. + Legal compliance including ISO/ FDA standards. + Performance - Talent/Competency Assessment to include work… more
- Sanofi Group (Northborough, MA)
- … walkthroughs and statistical analysis of results to process or equipment compliance to FDA and GMP requirements Interpreting complex, explicit documentation ... **Job Title:** Compliance Specialist Principal **Location** : Northborough, MA **About...for new and current procedures and FDA enforcement actions/trends + Completing analysis, identifying issues and… more
- Unilever (Englewood Cliffs, NJ)
- …with broad responsibilities ranging from marketing and advertising law, FDA /FTC compliance , data privacy, e-commerce, international expansion, litigation ... quality & regulatory, M&A, data privacy, and more. + Advise on compliance and legal issues related to dietary supplements, conventional foods, medical devices,… more
- Actalent (St. Paul, MN)
- …Continuous improvement and lean manufacturing. + Six Sigma. + GMP experience. + FDA compliance . Additional Skills & Qualifications + Slot die coating, comahead, ... Support the portfolio of TM products and projects in accordance with cGMP, FDA , and DEA regulations and standards. Responsibilities + Lead design reviews and… more
- Kelly Services (Abbott Park, IL)
- …for small in-house projects, as well as validating and producing drawings for FDA compliance . The ideal candidate is an Engineering Design Technician with ... projects. + **Validation Drawings** : Experience in producing validation drawings for FDA compliance . **Preferred Skills:** + Experience with Revit is highly… more
- GNC (Greenville, SC)
- …GNC's Stability Program under the Director of Quality Control. + Support monitoring of FDA Compliance Actions, FDA Dashboard Reporting, and Warning Letters ... product releases as well as routine inspection of existing products to ensure compliance with applicable regulations and GNC policy. + Develop, review, and approve… more
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