- Cordis (Miami Lakes, FL)
- …process/equipment validation (IQ/OQ/PQ) and test method validation (TMV) per 21 CFR 820, ISO 13485, and ISO 14971; set sampling plans and acceptance criteria. ... experience. **Preferred Qualifications** + Proven track record working within ISO 13485 and FDA-regulated environments. + Experience with process/product validation,… more
- University Surgical Center (10600) (Winter Park, FL)
- …budgeting, resourcing and performance evaluation procedures Excellent knowledge of standards (eg ISO ) and regulations for the clinical field Proficient in MS Office ... and computer systems (eg patient management software) Excellent communication and people skills Exceptional organizational and leadership skills Aptitude in resolving issues and conflicts Employment practices will not be influenced or affected by an… more
- USAA Careers (Tampa, FL)
- …working with and applying Risk, Security or Audit frameworks ( FFIEC, COBIT, COSO, ISO 27001/2, NIST 800-53, SSAE16 ). * Knowledge of applicable laws, rules, and ... regulations applicable to financial institutions. * Experience making data-driven decisions. * Experience working with external agencies and regulators. * Broad knowledge of information technology systems and general system development principles. What sets… more
- Cordis (Miami Lakes, FL)
- …insights. Regulatory & Systemic Expertise + Apply in-depth knowledge of ISO ?13485, FDA QSR, and global regulatory expectations to guide supplier compliance. ... or regulated manufacturing environments. **Preferred Qualifications** - Strong understanding of ISO ?13485, FDA QSR, supplier audits, and global QMS standards. - Lean… more
- USAA Careers (Tampa, FL)
- …working with and applying Risk, Security or Audit frameworks ( FFIEC, COBIT, COSO, ISO 27001/2, NIST 800-53, SSAE16 ). * Knowledge of applicable laws, rules, and ... regulations applicable to financial institutions. * Experience making data-driven decisions. * Experience working with external agencies and regulators. * Broad knowledge of information technology systems and general system development principles. What sets… more
- Cordis (Miami Lakes, FL)
- …preferably in a medical device environment. - Proven track record working within ISO 13485 and FDA-regulated environments. - Experience with risk management ( ISO ... 14971), design controls, and documentation practices. **Preferred Qualifications** - Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials. - Work includes potential exposure to radiation sources such as… more
- Cordis (Miami Lakes, FL)
- …balloon films. + Lead process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements. + Troubleshoot and resolve extrusion ... design, and equipment setup. + Experience with cleanroom manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/QSR. + Proficiency with statistical… more
- KBR (Jacksonville, FL)
- Title: Lead ISO 9001:2015 Auditor Belong, Connect, Grow, with KBR! Program Summary The Marine Corps Prepositioning Program (MCPP) is based in Jacksonville, Florida. ... by documenting audit tests and findings. You will maintain and ensure an ISO compliant library and assist with all commodities document libraries. You will assist… more
- Oracle (Tallahassee, FL)
- …healthcare solutions align with global medical device standards, including **IEC 62304, IEC 82304, ISO 13485, ISO 14971** , and related IMDRF SaMD guidance. You ... Regulatory, and Clinical teams to ensure product development conforms to ** ISO 13485** , ** ISO 14971** , EU MDR/IVDR expectations, and IMDRF SaMD risk… more
- Bausch + Lomb (Clearwater, FL)
- …Lead and manage microbiology laboratory operations, ensuring compliance with cGMP, ISO 13485, and FDA regulations. + Oversee microbiological testing programs, ... maintain sterilization validation protocols and reports in compliance with ISO 11135, ISO 11137, and related standards....and reports in compliance with ISO 11135, ISO 11137, and related standards. + Partner with manufacturing,… more
