- Beckman Coulter Diagnostics (Miami, FL)
- …environmental 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 ... certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as FDA… more
- Cytiva (Miami, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... 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
- Cytiva (Miami, FL)
- … medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP).2+ ... manufacturing processes, managing projects, and ensuring the efficient production of high- quality medical devices and products in a regulated environment.… more
- Beckman Coulter Diagnostics (Miami, FL)
- …a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this ... 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
- Abbott (Temecula, CA)
- …projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives. . Acts as a ... **RESPONSIBILITIES:** . Provides design assurance support in design and development of medical device products and facilitate the application of design controls… more
- Abbott (Irving, TX)
- …Teamcenter Product Data Management & IBM DOORS. + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, 21 ... TX location is looking for a Sr. Software Design Quality Engineer. This person will be responsible to review...design control for On-Market and In-Development activity in the Medical Device space. It is expected to… more
- Abbott (San Diego, CA)
- …**Preferred Qualifications** + Masters degree preferred + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Irving, TX)
- …process in a team-oriented environment. + Strong Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, ... TX has an open opportunity for a Principal Design Quality Engineer, Risk Management. This person will be responsible...design control for On-Market and In-Development activity in the Medical Device space. It is expected to… more
- Philips (Murrysville, PA)
- …+ You've acquired a minimum of 10+ years' experience working in FDA regulated medical device quality environments, with a deep understanding of ISO 13485 ... QMS, compliance, and regulatory requirements related to medical device product holds/releases (highly preferred). + You have proven experience in… more
- J&J Family of Companies (Springfield, IL)
- …moral character while professionally representing the company. + Comply with all corporate compliance, FDA , medical device , quality standards and ethics. ... multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's license. + Operate as a team and/or… more
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