| Resume alert | Resumes 111 - 120 of 460 |
Manager Engineer
Tyngsborough, MA
... Maintains and enhances quality management systems as related to FDA’s 21 CFR 820, ISO 9001, ISO 13485 and AS9100D. Assures that appropriate procedures and requirements are in place and effective in controlling materials, facilities and products ... - 2019 Dec 15
... Maintains and enhances quality management systems as related to FDA’s 21 CFR 820, ISO 9001, ISO 13485 and AS9100D. Assures that appropriate procedures and requirements are in place and effective in controlling materials, facilities and products ... - 2019 Dec 15
Medical Device Manager
Medford, MA
... analytical validation, technology transfer, GMP, GCP, CLIA, FDA, ISO guidance, troubleshooting 3 + years projects management experience: control documents, ANDA, PMA and 510(k) projects, IRB file Education Rice University, Houston, TX Dec. ... - 2019 Oct 17
... analytical validation, technology transfer, GMP, GCP, CLIA, FDA, ISO guidance, troubleshooting 3 + years projects management experience: control documents, ANDA, PMA and 510(k) projects, IRB file Education Rice University, Houston, TX Dec. ... - 2019 Oct 17
PharmD Patient Counseling, AE Reporting, CMS, Inventory P&L, DUR
Boxford, MA
... Skills Knowledge of ICH, FDA guidelines Knowledge of Quality Management Systems Medicare/Medicaid Data Entry / 80 WPM Drug Utilization Review Inventory Control Strong written and oral interpersonal communication skills Advanced in Microsoft Office ... - 2019 Oct 04
... Skills Knowledge of ICH, FDA guidelines Knowledge of Quality Management Systems Medicare/Medicaid Data Entry / 80 WPM Drug Utilization Review Inventory Control Strong written and oral interpersonal communication skills Advanced in Microsoft Office ... - 2019 Oct 04
Mechanical Engineer Designer
Hamilton, MA
... • Familiar with variety kinds of polymers to meet FDA regulations. Axcelis Technologies, an semiconductor equipment company, Pro/E Mechanical De-signer 2005 – 2007 • Mechanical design and detail for the electrostatic chuck for the Optima HD. The E ... - 2019 Sep 28
... • Familiar with variety kinds of polymers to meet FDA regulations. Axcelis Technologies, an semiconductor equipment company, Pro/E Mechanical De-signer 2005 – 2007 • Mechanical design and detail for the electrostatic chuck for the Optima HD. The E ... - 2019 Sep 28
Engineer Quality
Sandown, NH, 03873
... (Temporary Contract) Support the function of Supplier Quality Engineer and test engineer, Quality V&V test support, ECOs, NCMRs, FAIs, Approved Supplier List, and receiving inspection supervision within the QMS of ISO 13485, ISO 9001, and FDA ... - 2019 Sep 26
... (Temporary Contract) Support the function of Supplier Quality Engineer and test engineer, Quality V&V test support, ECOs, NCMRs, FAIs, Approved Supplier List, and receiving inspection supervision within the QMS of ISO 13485, ISO 9001, and FDA ... - 2019 Sep 26
Manager Clinical Research
Marblehead, MA
... CRA monitoring a post FDA approved Medtronic insulin pump study with a closed loop CGM system following glycemic control among enrolled Type 1 diabetic subjects Therapeutic areas: Type 1 Diabetes, Insulin pumps, Class 3 Medical Devices Ensured scope ... - 2019 Sep 20
... CRA monitoring a post FDA approved Medtronic insulin pump study with a closed loop CGM system following glycemic control among enrolled Type 1 diabetic subjects Therapeutic areas: Type 1 Diabetes, Insulin pumps, Class 3 Medical Devices Ensured scope ... - 2019 Sep 20
Quality Assurance Director level
Boston, MA
... Strong FDA / EMEA experience. Subject Matter Expert in injectable formulation PAI Preparation, Quality and Compliance, Material Qualification, Process Validation and Multi Product Facilities. Pre-IND through NDA/BLA (including eCTD) and post ... - 2019 Jul 30
... Strong FDA / EMEA experience. Subject Matter Expert in injectable formulation PAI Preparation, Quality and Compliance, Material Qualification, Process Validation and Multi Product Facilities. Pre-IND through NDA/BLA (including eCTD) and post ... - 2019 Jul 30
Embedded Software Engineer
Stratham, NH, 03885
... Novocure Inc., Portsmouth, NH 2014-2015 Validation & Verification Software Engineer ● Designed, developed and prepared for FDA approval requirements and testing procedures for embedded software running in medical device for brain cancer ... - 2019 Jul 18
... Novocure Inc., Portsmouth, NH 2014-2015 Validation & Verification Software Engineer ● Designed, developed and prepared for FDA approval requirements and testing procedures for embedded software running in medical device for brain cancer ... - 2019 Jul 18
Manager Plant
Lowell, MA
... Green card holder Education Master of Science in Organic Chemistry, Gujarat University, Gujarat, India April 1989 Bachelor of Science in Chemistry, Gujarat University, Gujarat, India May 1985 Approved Manufacturing chemist by Gujarat, FDA (INDIA). ... - 2019 May 16
... Green card holder Education Master of Science in Organic Chemistry, Gujarat University, Gujarat, India April 1989 Bachelor of Science in Chemistry, Gujarat University, Gujarat, India May 1985 Approved Manufacturing chemist by Gujarat, FDA (INDIA). ... - 2019 May 16
Quality Manager
Merrimacport, MA, 01860
... Instituted a comprehensive "rehabilitation program” for a Pharma Company shut down by the FDA and transformed it into a sustainable GMP compliant operation. I consider myself a hybrid(trifecta)in Clinical/CMC Regulatory Affairs, Drug Development and ... - 2019 May 14
... Instituted a comprehensive "rehabilitation program” for a Pharma Company shut down by the FDA and transformed it into a sustainable GMP compliant operation. I consider myself a hybrid(trifecta)in Clinical/CMC Regulatory Affairs, Drug Development and ... - 2019 May 14