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FDA jobs in Cambridge, MA

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Job alert Jobs 1 - 10 of 984

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

Principal Manufacturing Engineer

BlackTree Technical Group, Inc.  –  Newton, MA
... All procedures and processes must comply with FDA and ISO standards. This is a working position in a start-up environment and will allow the individual to build a team as the business needs arise. BS in Engineering or Science required. Minimum of 7 ... - May 18

Regulatory Affairs and Quality Assurance Associate

American Surgical Company  –  Salem, MA, 01971
... You are experienced with EU MDR, ISO 13485, FDA 510(k), and PMA. You possess strong analytical skills and are capable of interpreting complex regulatory documents. Excellent communication skills and the ability to work well under limited supervision ... - May 24

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 17

Sr. Statistical Programmer -remote (East Boston)

SimulStat  –  East Boston, MA
... Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, ... - May 24

Director of Clinical Operations

Global Life Science Hub  –  Boston, MA
... Strong understanding of FDA, EMA, and PDMA regulations and guidelines. Exceptional written and verbal communication skills. Strong ethical values and ability to build and lead high-performing teams. Apply: The Global Life Science Hub are a niche ... - May 16

HCG - MES Engineer

Horizon Controls Group  –  Boston, MA, 02108
... Compliance and Regulatory Support: Stay up to date with relevant regulatory guidelines and industry standards (e.g., FDA, GMP) pertaining to MES systems. Assist in ensuring compliance with these regulations through proper system configuration, data ... - May 09

Supply Chain Engineer

InfraredX, Inc.  –  Bedford, MA, 01730
... Knowledge of regulatory requirements and quality standards applicable to medical device manufacturing (e.g., FDA regulations, ISO standards) is a plus. Six Sigma, Lean, or other process improvement certifications are desirable. Advanced computer ... - May 23

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 16

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 ... - May 04
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