- Cytiva (Miami, FL)
- …about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional ... QA, Operations, or Quality Engineering preferred.Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA... Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality … more
- Aldevron (Miami, FL)
- …and delivery of solutions that safeguard and improve human health.The Sr. Client Quality Manager is responsible for overseeing all duties related to the ... regulatory agency inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past Quality... FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ, etc.)Strong… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a part of the Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality Management ... GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This... certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as FDA… more
- Cytiva (Miami, FL)
- …manufacturing or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - ... manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment. The ideal… more
- Beckman Coulter Diagnostics (Miami, FL)
- …part of the Quality Assurance - Validation team and report to the Quality Assurance Manager responsible for Validation. If you thrive in a multifunctional, ... Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located in Chaska, MN and will be on-site.… 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 ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method… 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 ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation and will be responsible for representing the Analytical… more
- Aldevron (Miami, FL)
- …Operational Quality Assurance team and report to the Sr. Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures ... safeguard and improve human health.This position is part of Quality Assurance located in Fargo, ND and will be...(cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations specific to labels and labeling… more
- Actalent (Longmont, CO)
- Job Title: Quality Manager Job Description We are seeking a dedicated Quality Manager to develop and maintain a quality management system that ... quality management system in compliance with ISO:2016 and FDA regulations. + Conduct internal and external quality... FDA regulations. + Conduct internal and external quality audits to ensure adherence to regulatory standards. +… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …to ensure compliance with all regulatory requirements. The estimated pay scale for the Quality Assurance Technical Manager role based in Los Angeles, CA, is $95k ... and regions. _Job Summary:_ Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation… more
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