| Resume alert | Resumes 91 - 100 of 523 |
Medical Quality
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
... • 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
Engineering Engineer
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
... 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
Engineer Engineering
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
... 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
Assistant Document Control
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
... 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
Quality Service
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
... 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
Logistic Coordinator
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
... * 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
Data Engineer
Ipswich, MA
... Supported FDA Licensed/regulated medical/clinical Devices for sister company Datex-Ohmeda Implemented and maintained Enterprise Application Integration (EAI) interface solutions for major hospital installations in U.S. and Canada using the - 2020 Nov 19
... Supported FDA Licensed/regulated medical/clinical Devices for sister company Datex-Ohmeda Implemented and maintained Enterprise Application Integration (EAI) interface solutions for major hospital installations in U.S. and Canada using the - 2020 Nov 19
Nurse Practitioner Registered
Cambridge, MA
... overall Project Management of multi-center Neurological Disorders Clinical Research Trials • Member of multiple study trial teams, working with PI’s to develop protocols, amendments, consent forms and revisions in line with IRB and FDA regulations. ... - 2020 Nov 17
... overall Project Management of multi-center Neurological Disorders Clinical Research Trials • Member of multiple study trial teams, working with PI’s to develop protocols, amendments, consent forms and revisions in line with IRB and FDA regulations. ... - 2020 Nov 17
Safety Medical
Brookline, MA
... CSR, Synoptic CSR, and Supplemental CSR), IB updates, FDA briefing Documents, PRAC Response to Questions (RTQs), Risk Management Plan (RMPs), Risk Evaluation and Mitigation Strategy (REMS), Clinical Overview documents, PSURs, DSURs and PBRER. ... - 2020 Nov 16
... CSR, Synoptic CSR, and Supplemental CSR), IB updates, FDA briefing Documents, PRAC Response to Questions (RTQs), Risk Management Plan (RMPs), Risk Evaluation and Mitigation Strategy (REMS), Clinical Overview documents, PSURs, DSURs and PBRER. ... - 2020 Nov 16
Water Treatment Forklift Operator
Lowell, MA
... Maintain inventory locations within an FDA compliant warehouse. Pick internal build orders for manufacturing. Pick, pack and ship external customer parts orders utilizing FedEx and DHL. Participate in cycle counting activities. Shipper & Receiver ... - 2020 Oct 27
... Maintain inventory locations within an FDA compliant warehouse. Pick internal build orders for manufacturing. Pick, pack and ship external customer parts orders utilizing FedEx and DHL. Participate in cycle counting activities. Shipper & Receiver ... - 2020 Oct 27