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FDA jobs in Boxford, MA

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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

Director of Regulatory and Quality

Michael Page  –  Danvers, MA, 01923
Reporting into the General manager, The Director of Quality & Regulatory will maintain and enhance the current ISO 13485, FDA cGMP and Canadian Medical Devices Conformity Assessment System (CMDCAS), Complaint system, and Quality Management System ... - Jun 03

Sr. Software Engineer (LOCAL CANDIDATES ONLY)

Connexion Systems & Engineering, Inc.  –  Andover, MA
... and system test plans and procedures Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304 Manage procedures and deliverables for software verification Address field complaints by determining ... - May 31

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

Cleanroom Production Associate

Monroe Staffing  –  Danvers, MA
... in daily activities • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations Job Qualifications (minimum requirements): • High School Graduate or equivalent manufacturing experience • ... - May 16

Clinical Operations Manager

Access Vascular  –  Billerica, MA
... Regulatory Compliance: Maintain strict adherence to relevant regulations (e.g., FDA, ISO) throughout the trial lifecycle. Accurately document all compliance-related activities. Study Oversight: Monitor study progress, patient recruitment, data ... - Jun 02

Project Manager- must have med device & quality engineer experience

Diverse Lynx  –  Danvers, MA, 01923
... • Knowledge on Quality Management and its tools & techniques • Knowledge about FDA, ISO 13485 and compliance regulations • Knowledge on Medical Device Regulatory Standards, MDD and MDR • Knowledge on NC, CAPA, Audit processes • Knowledge in ... - May 29

Principal Supplier Quality Engineer

InfraredX, Inc.  –  Bedford, MA, 01730
... Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements. Lead the review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval. Generate KPI’s and ... - May 16

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, ... - Jun 04

Software Engineer

Engtal  –  Andover, MA
... Formulate and uphold software development protocols in compliance with regulatory standards, including FDA guidance and IEC 62304. Oversee procedures and deliverables for software verification. Investigate field complaints to ascertain root cause ... - May 15
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