- Beckman Coulter Life Sciences (Indianapolis, IN)
- …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)
- …of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP, ... FDA knowledge and other ISO standards an advantage.Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking,… more
- Cytiva (Miami, FL)
- …communication and supplier auditing.Demonstrated knowledge of Quality Management System ( ISO 9001 or equivalent), cGMP, continuous improvement methodologies, and ... if you also possess previous experience in:Medical Device, eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our winning team today.… more
- Cytiva (Miami, FL)
- …communication and supplier auditing.Demonstrated knowledge of Quality Management System ( ISO 9001 or equivalent), cGMP, continuous improvement methodologies, and ... if you also possess previous experience in:Medical Device, eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent SpanishCytiva, a Danaher… more
- Cytiva (Miami, FL)
- …and improve process performance ensuring compliance with regulatory requirements (eg, FDA, ISO , PSM) and contribute to audits and inspections as necessary.Who you ... 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)
- …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, ... etc.)Strong EQPreferred QualificationsExperience in cell and therapy or biological manufacturing is a plusExperience in cell and therapy or biological manufacturing is a plus#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life… more
- Cytiva (Miami, FL)
- …years of experience in Quality or Regulatory in a regulated industry ( ISO 9001, medical device, or pharmaceutical preferred).Experience with root cause analysis, ... in:Experience in a regulated environment such as medical devices ( ISO 13485), pharmaceuticals (GMP), or biotechnology.Proficiency with quality management systems… more
- Beckman Coulter Diagnostics (Miami, FL)
- …quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.It would be ... a plus if you also possess previous experience in:Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (eg CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)Expert understanding of Danaher… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …Products (Word, Excel, PowerPoint) or equivalent software applications is preferred. Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management ... system requirements and IVD products. #LI-LCSJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges,… more
- Beckman Coulter Diagnostics (Miami, FL)
- …equipment, process, and/or design testing methodologies.Knowledge of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System Validation ... (CSV) and process validationIt would be a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this role is 100K-115K. This is the range that we in good faith… more
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