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FDA jobs in Cambridge, MA

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Job alert Jobs 1 - 10 of 833

Medical Technologist

Wealth Recruitment, LLC  –  Boston, MA
75000.00 - 105000.00
... JC, CAP, FDA, AABB) requirements. Requires the manual/visual dexterity necessary to prepare specimens, prepare solutions, screen specimens and operate a computer software system. Requires interpersonal and English verbal and written language skills ... - Mar 14

Senior SQA Analyst - Veeva CRM

RCM Technologies, Inc.  –  Boston, MA, 02298
... Qualifications: Strong understanding of FDA guidance on electronic records and validation procedures Experience working with a Pharmaceutical, Biotech or Medical Device organization. Experience working with Jira. Experience working in an agile ... - Jun 18

Maintenance Engineering Specialist (SAP & Maximo)

Validation & Engineering Group  –  Cambridge, MA, 02138
... upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards. ... - Jun 19

Associate Director, Regulatory Affairs

Bicycle Therapeutics Limited  –  Cambridge, MA, 02140
... preferred Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry Working knowledge of FDA, EMA and ICH regulatory guidance and regulations Experience and knowledge in preparation of INDs, CTAs, NDAs, MAAs or ... - Jun 20

Manufacturing Engineer

Stark Associates LLC  –  Foxborough, MA
... Coordinate with Quality Assurance and Research and Development to uphold an approved internal Quality System meeting FDA QSR and ISO 13485 requirements. Aid in pilot production of various products, establishing lean manufacturing cells to enhance ... - Jun 20

Engineer: Manufacturing

Nanobiosym  –  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 ... - Jun 03

Director of Quality

Lumicell  –  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 ... - Jun 15

Engineer: Process Improvement Engineer

Nanobiosym  –  Cambridge, MA
... Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team with details of root cause analysis. ... - Jun 13

Quality Control Inspector

Lab Medical Manufacturing  –  Billerica, MA
... is an ISO 13485 certified/FDA registered company and has been manufacturing machined and finished assembly products for the medical industry for over 35 ; Summary of Position: LAB Medical Manufacturing, Inc. is s... - Jun 13

Senior Supplier Quality Engineer

InfraredX, Inc.  –  Bedford, MA, 01730
... Maintains supplier quality records in accordance with FDA/GMP and EU MDR requirements. Coordinate review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval. Assist with ... - May 24
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