- Beckman Coulter Diagnostics (Miami, FL)
- …including GMP and QSR requirements for medical devices. (ISO13485, FDA 's QSRs, EU's MDD, Canadian Regulations) is required. Proficiency in the Microsoft ... certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as FDA... quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO… more
- Aldevron (Miami, FL)
- …in a Quality with experience working in a regulated or GMP compliant environment and leading projects or related experience.Exposure to regulatory agency ... inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past ... FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ, etc.)Strong… more
- Cytiva (Miami, FL)
- …production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP ).2+ years experience ... manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment. The ideal… more
- Pall (Miami, FL)
- …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 ... Pall is there, helping protect critical operating assets, improve product quality , minimize emissions and waste, and safeguard health. For the exponentially… more
- Aldevron (Fargo, ND)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... validation with minimal assistance.Collaborate with Analytical Method Development and Quality Control (QC) Laboratory Associates to support the implementation of… more
- Aldevron (Fargo, ND)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... and instrumentation. Work closely with Analytical Method Development and Quality Control (QC) Laboratory Associates to ensure successful implementation of… more
- Kelly Services (South San Francisco, CA)
- …the pharmaceutical or biotechnology industry. + Strong understanding of regulatory requirements ( FDA , EMA, ICH, GMP ) and quality management principles. ... ** Quality Systems Specialist** Kelly(R) Science & Clinical is seeking a Quality Systems Scientist for **a temp-to-hire** position at **an early-stage biotech**… more
- Sanofi Group (Framingham, MA)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- AMETEK.Inc (Mansfield, MA)
- …years' experience in manufacturing operations with medical devices. + Knowledge and experience with GMP , ISO, FDA , and quality standards + Experience with ... medical devices as required by clients. Requires adherence to Good Manufacturing Practices ( GMP ) and FDA , ISO, and environmental requirements and must adhere to… more
- Aerotek (Eden Prairie, MN)
- …and collaborate with teams to maintain quality standards ✔️ Ensure compliance with ** GMP , FDA Quality System Regulations (QSR), and ISO guidelines** ✔️ ... Identify process improvements to enhance efficiency and product reliability ✔️ Help train new team members on best practices **What We're Looking For:** **Experience:** 0-2 years in assembly or manufacturing (regulated industry experience preferred)… more
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