- Stryker (Mahwah, NJ)
- …Collaborate with Quality, Regulatory, and Advanced Technology to ensure compliance with FDA , ISO, and internal standards. + Identify and implement NPI best practices ... preferred) + Strong knowledge of DFM, process validation, and quality systems ( FDA , ISO 13485) **Preferred Qualifications:** + Experience with investment casting or… more
- Cordis (Miami Lakes, FL)
- …Regulatory & Systemic Expertise + Apply in-depth knowledge of ISO 13485, FDA QSR, and global regulatory expectations to guide supplier compliance. + Conduct ... manufacturing environments. **Preferred Qualifications** * Strong understanding of ISO 13485, FDA QSR, supplier audits, and global QMS standards. * Lean Six… more
- Sysco (Auburndale, FL)
- …industry standard safety policies and procedures - OSHA, NEC, NFPA, USDA, FDA , etc. + Perform inspections and complete preventive/predictive maintenance tasks on ... + Experience working in a food processing environment and familiar with USDA, FDA , and SQF policies and procedures. **Education** High School Diploma or GED… more
- CBRE (Reno, NV)
- …CBRE self inspection, client self inspections, or any external agency inspections like the FDA . Has the responsibility to lead audits as well as serve as the primary ... preferred. Previous supervisory experience a plus. **CERTIFICATES and/or LICENSES** FDA , ISO, or similar quality assurance audit related certification preferred.… more
- Chiesi (Boston, MA)
- …Regulatory and Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and decision-making across global markets. ... would prefer for you to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE submissions. + Knowledge of health policy, payer dynamics, and HTA… more
- Stryker (Mahwah, NJ)
- …& Validation: + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards. + Establish robust process controls and capability ... (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: Medical and prescription drug… more
- WuXi AppTec (Middletown, DE)
- …construction management, schedule, safety management, process, commissioning & qualification per GMP/ FDA compliance. + Own the development and delivery of the ... and regulations while maintaining international standards + Good acknowledge of GMP/ FDA /ICH and implementation + Strong teamwork spirit + Strong communication and… more
- UPMC (Pittsburgh, PA)
- …of their specific projects. + Routinely monitors all trials for compliance with FDA , UPMC and IRB compliance; promptly and effectively reports any issues to ... and retrospective data. + Oversee and coordinate governmental audits such as the FDA and NCI. + Develop and maintain outcomes and disparities clinical research… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... equipment (both upstream and downstream). + Strong knowledge of GMP, FDA , cGMP, and international regulatory requirements. + Hands-on experience developing and… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... English; additional language skills are a plus. Preferred Skills: + Experience with FDA , EMA, or other regulatory inspections. + Familiarity with software tools used… more