| Job alert | Jobs 41 - 50 of 850 |
Head Of Quality
MRINetwork Jobs
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Newton, MA, 02458
... Maintain and enhance a comprehensive quality management system (QMS) to ensure alignment with cGMP and other regulatory requirements across both clinical and commercial operations for FDA-regulated medical devices and drugs Develop and implement ... - May 26
Engineer: Manufacturing
Nanobiosym
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Cambridge, MA
... Develops and implements validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Conducts root cause analysis of product quality issues. QUALIFICATIONS S. or B.S. in Engineering (Plastics or Mechanical preferred) Six Sigma Black Belt, a ... - May 04
Director Quality Operations
EPM Scientific
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Cambridge, MA, 02140
... Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with cross-functional teams to ensure seamless product launches. Proactively identify ... - May 11
Laboratory Evening Supervisor- MT (ASCP)
Lawrence General Hospital
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Lawrence, MA, 01842
... Knowledgeable of regulatory compliance standards for CAP, TJC, OSHA, FDA, and DPH.# Participates in the selection, training, and evaluation of laboratory staff and students.# Initiates or recommends personnel action as appropriate. Evaluates entry ... - May 21
X-ray FSE
Cephas Consultancy Services Private Limited
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Boston, MA
... Completion of all necessary state and FDA required paperwork associated with the installation of radiation generating equipment. Ordering of parts and supplies required to maintain equipment and tickets assigned. Maintains a working knowledge and ... - May 15
Staff Design Quality Engineer
Butterfly Network
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Burlington, MA
... to ensure compliance to FDA 21 CFR 820, MDD/MDR, ISO 13485,ISO 1497, IEC 62304 and Butterfly’s procedures Collaborating with Quality Systems and cross-functional teams to implement electronic tools for documents management, bug tracking, etc. ... - May 13
Senior Compliance Auditor
Planet Professional
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Cambridge, MA, 02140
... Knowledge of relevant FDA regulations/guidance and ICH Guidelines. Ability to plan/execute and report audits independently. Experience in cell manufacturing/biologics, medical devices, and/or software quality. Exposure to Good Clinical Practice (GCP ... - May 11
Principal Regulatory Specialist
Amplitude Vascular Systems
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Boston, MA, 02298
... Experience with FDA IDE and PMA submissions. Knowledge/skills/Abilities: Knowledgeable of FDA (21CFR 812, 820), ISO 13485, and ISO14971 Thorough understanding of FDA and applicable international regulations. Excellent written and oral communication, ... - May 13
Clinical Research Associate
Anteris Tech
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Boston, MA
... Experience with site- and sponsor-level FDA BIMO investigation(s) Excellent written and verbal communication, presentation, interpersonal, and analytical skills required. Experience working with CROs, core labs and other external vendors ... - May 22
Chief Technical Officer (Small Molecule)
Kennedy Bond
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Boston, MA, 02298
... Ensure quality oversight for FDA readiness, oversee tech transfer, batch record review, validation, comparability studies, fill finish, change control, etc.; Ensure timely delivery of drug substance and drug product for discovery initiatives; ... - May 23