- Stryker (San Jose, CA)
- …+ Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems. + Promote a customer-centric ... As a **Staff NPI Quality Engineer** , you will provide quality...and maintain process risk documentation per ISO 14971 for regulatory submissions. + Investigate and close non-conformances and CAPAs… more
- Conagra Brands (Louisville, KY)
- Reporting to the Food Safety, Quality and Regulatory Affairs Director, located at our Louisville, KY facility, you will ensure food safety and quality for ... safety issues, implementing corrective actions as needed. + Maintain compliance with USDA, FDA , CFIA, and other regulatory requirements, acting as liaison with… more
- Cardinal Health (Indianapolis, IN)
- … policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Control is responsible for the ... experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. +...agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member… more
- Medtronic (Newton, MA)
- … and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO ... + Advanced degree in a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or similar). **\#LI-MDT** **Physical Job… more
- Genentech (Hillsboro, OR)
- …to bring transformative therapies to patients. This role is a part of our Quality Systems and Validation (QSV) team, which is dedicated to supporting the design, ... closely with stakeholders across Clinical Facilities, Technical Development, and Global Quality to define and implement robust Quality Systems, Validation… more
- Otsuka America Pharmaceutical Inc. (Columbia, SC)
- …**Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA , EMA, PMDA) and internal standards. + Support ... Veeva, TrackWise). + Familiarity with digital transformation and data analytics in quality operations. + Prior involvement in regulatory inspections and audit… more
- Abbott (Pomona, CA)
- …development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Perform other duties and projects ... to QA activities for regulatory compliance (ie Management Review support, regulatory audits). + Assist in determining quality attributes and requirements.… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and align with current GMP ... training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- …protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices ... **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …products and materials. + Supports implementation of projects that improve site Quality and/or efficiency. + Support internal and external/ regulatory audits / ... Quality Control Document Specialist Department: Chemistry Location: Monroe,...(Functional / Technical) Strong understanding of CGMP/GLP and related regulatory health authority guidance ( FDA regulations, ICH… more