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Resumes 91 - 100 of 527 |
Dorchester, MA
... SKILLS Calibration Chemistry CLIA Compliance FDA Hematology Inspection ISO/IEC 17025 Internal Audits Laboratory equipment Laboratory testing Personnel Policies Quality Assurance QA Quality Control Research Safety Surveys Technical support Validation ...
- 2021 Mar 24
Quincy, MA
... Became familiar with due diligence process including researching materials, developing a prototype, and complying with FDA regulations. Material selection was a focal point of this project. Automated Chest Compression Device January 2020-May 2020 ...
- 2021 Feb 25
Lexington, MA
... 2020 • Teamed with system developments to build operation tools that facilitate FDA pharmaceutical surveillance • Implemented Django backend and Bokeh to develop application tools and visualizations for FDA Querying • Experienced Agile development ...
- 2021 Jan 21
Billerica, MA
... The BSC Gateway sends the eMDR 3500A XML files to the FDA Gateway using a secure digital certificate. The digital certificate identifies submissions from Boston Scientific Worked on URDs and Business requirements Worked on functional requirements to ...
- 2021 Jan 18
Boston, MA
... • Well versed with FDA Forms: 1571, 1572, 3674, 3454, 3455, 3500, 3500A, 3962, 483, Warning Letters and Type A, B, (Pre-IND &EOP 2), & C meetings. • Possess a thorough understanding and implementation of ISO 13485, ISO9001, ISO62304, and ISO14971 • ...
- 2021 Jan 03
Andover, MA
... Maxtec is a medical company and we followed ISO 14971 standards for FDA approval and compliance. President, Excalibur Engineering LLC (1992 to 2004) Excalibur Engineering is a company I cofounded. My responsibilities included sales, manufacturing ...
- 2020 Dec 18
Boston, MA
... Performed validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ/TMV/ETR) in compliance with FDA regulations and ISO 9001, ISO 14001 & OHSAS 18001 standards Key Results Include: • ...
- 2020 Dec 13
Norwood, MA
... FDA and ICH guidelines; the roles of CRA and CRC; the types of monitoring visits; the role of IRBs; Safety, Accountability, and Regulatory Compliance. Northeastern University, Level Program, Online Introduction to Data Analytics November 2018- ...
- 2020 Dec 12
Lowell, MA
... Familiarity with FDA Title 21, CFR820.100, CFR820.198, CFR803, ISO 9001, ISO 13485:2016, ISO 14971:2019, and other medical device regulations. Exceptional ability to handle multiple tasks and conduct with accuracy and high attention to detail. ...
- 2020 Dec 10
Brighton, MA
... * Brighton, MA 02135 617-***-**** adh2sh@r.postjobfree.com WORK HISTORY NanoEnTek America, Inc., Waltham, MA June 2020 – Oct 2020 Logistics Coordinator Coordinated international and domestic shipments of FDA approved medical products Processed ...
- 2020 Nov 23