- Cepheid (Miami, FL)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... Cepheid QMS to identify and implement improvements and ensuring that all internal audit findings are closed in a timely manner with effective corrective action.… more
- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) as well as all other...Audits and assists in the preparation and submission of audit responses and requests for information to FDA, MDSAP… more
- Pall (Miami, FL)
- …and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and ... (eg, ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May… more
- Collins Aerospace (Cedar Rapids, IA)
- …technical configuration analysis, change control facilitation, hardware/software management, audit and inspections, incident response and troubleshooting, etc.You ... of rapidly changing demands. Some of our competitive benefits packages include: Medical , dental, and vision insurance.Three weeks of vacation for newly hired… more
- Beckman Coulter Diagnostics (Miami, FL)
- …Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation.Support the in-house biorepository by receiving, shipping, and ... with 5+ years of clinical trial experience in vitro diagnostics (IVD), medical device, or healthcare clinical field.Demonstrated agility with processes and details,… more
- Cytiva (Miami, FL)
- …testing, and sterility assurance processes in a highly regulated medical device environment.This role involves conducting laboratory analyses, maintaining critical ... Environmental Monitoring, Water Testing, Compressed Gas Testing, Quarterly Dose Audit , Growth Promotion and Sterility Verification).Provide support as a… more
- Cytiva (Miami, FL)
- …do:Responsible for the sterility assurance program at site level. This includes dose audit program and provide expertise for transfer of work and capacity expansion ... control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and industry… more
- Raytheon (Tucson, AZ)
- …ability to work as a team member is essential.Ability to audit and perform quality control functions.Demonstrated ability to work independently.Excellent ... may be eligible for benefits, including but not limited to, medical , dental, vision, life insurance, short-term disability, long-term disability, 401(k) match,… more
- Cepheid (Miami, FL)
- …IVD regulations for other geographies (eg, Asia, Africa, and Latin America)FDA audit (eg, BIMO) processPhysical Demands:Must be able to travel approximately 10%The ... pay.We offer comprehensive package of benefits including paid time off, medical /dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay… more
- Cytiva (Miami, FL)
- …(SCR).Provide input and conducting supplier audits as on approved supplier audit schedule.Develop and execute Corrective and Preventive Action plans with suppliers ... would be a plus if you also possess previous experience in: Medical Device, eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent SpanishCytiva,… more
