| Job alert | Jobs 61 - 70 of 747 |
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
Quality Control Manager
North Coast Seafoods
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Boston, MA
... root cause analysis and corrective action Plan, prepare and participate in all audits including: organic, kosher, customer, FDA, internal and 3rd party Sustain and improve ratings on annual certifications Performs other related duties as assigned ... - Jun 02
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
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
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
Quality Assurance Manager
Veritas Search Group
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Boston, MA, 02298
... - Oversee change controls, complaints, investigations, CAPAs, IQ/OQ/PQ protocols and reports, specifications, and stability protocols to ensure compliance with regulatory requirements (FDA/ICH/ISO). - Review and approve lot analytical methods, ... - May 19
Quality System Associate
Meridian Bioscience, Inc.
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North Billerica, MA
... Ensure compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and ... - May 16
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
Senior Mechanical Engineer
Cytrellis Biosystems
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Woburn, MA, 01801
... What makes Cytrellis different: ️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. ️ Untapped Market Potential: 5x account growth in the last 8 months ️Voted Best Non ... - May 15