- Cytiva (Pensacola, FL)
- …therapeutics from discovery to delivery.What you will do:Quality Leadership & Compliance : Serve as the Pensacola site's Quality Management Representative, leading ... QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality goals.Quality Management System (QMS): Implement, maintain, and optimize… more
- Beckman Coulter Life Sciences (Miami, FL)
- …for Beckman Coulter Life Science.Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product ... particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring compliant process and product… more
- Pall (Miami, FL)
- …and/or procedures advises on impact of regulations, devises strategies for compliance , and liaison with regulatory bodies. Investigates and resolves compliance ... and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare… more
- Beckman Coulter Diagnostics (Miami, FL)
- …Review Board (CRB). This position is part of the Global Quality System and Compliance Group located in Brea, California, USA and will be on-site. At Beckman Coulter, ... work to build a world-class Global Quality System and Compliance organization-read on.In this role, you will have the...standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable… more
- Cytiva (Miami, FL)
- …for providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root ... improvement projects.Participate in Deviation and Concession Control Boards, ensuring compliance with quality standards.Implement process improvement initiatives using Six… more
- Cytiva (Miami, FL)
- …to resolve non-conformance issues (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring ... communication and supplier auditing.Demonstrated knowledge of Quality Management System ( ISO 9001 or equivalent), cGMP, continuous improvement methodologies, and… more
- Cytiva (Miami, FL)
- …to resolve non-conformance issues (QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring ... communication and supplier auditing.Demonstrated knowledge of Quality Management System ( ISO 9001 or equivalent), cGMP, continuous improvement methodologies, and… more
- Cytiva (Miami, FL)
- …or systems to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA, ISO , PSM) and contribute ... years experience with regulatory standards and quality systems (eg, FDA, ISO 13485, Good Manufacturing Practices - GMP).2+ years experience with PSM/engineering… more
- Aldevron (Miami, FL)
- …risk assessment using FMEA, HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.Job QualificationsBachelor ... to regulatory agency inspections or other types of audits (eg, FDA, notified bodies, ISO , etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ,… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …opportunity to: Contribute to the continuous improvement of product safety + compliance by effectively managing and resolving quality complaints Communicate with ... Products (Word, Excel, PowerPoint) or equivalent software applications is preferred. Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management… more
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