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Capa resumes in Buffalo, NY

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Regulatory Affairs- Medical Affairs Executive

East Amherst, NY
... Prompted the company to revisit its corrective and preventative action procedures (CAPA). Regulatory Planning and Pathway Development Raised investor confidence and cleared the path for additional funding for a bone healing device. Developed ... - Jan 18

Quality Engineer

Lockport, NY
... • Initiate Change Controls, Deviations, and CAPA as needed to Quality systems, as specified within the individual Client Quality Agreements. • Perform USP Compendial Raw Material Pharmaceutical analysis as requested, both wet and instrumental ... - 2021 Feb 28

Medical Device

Buffalo, NY
... R&D team to evaluate new medical devices from Phase I through Phase V ●Extensive knowledge of GLP, GCP, GDP, cGMP, and CAPA ●Background of conducting audits and quality inspections for pre-FDA Medical Device & Drug Discovery studies ●Created 510 ... - 2020 Nov 05

Process

Buffalo, NY
... Root Cause Analysis, Data Analysis, Quality Improvement, TPM, Yield Improvement, Time and Motion Studies, DMAIC, 8D, 5S, CAPA, PFMEA, Kaizen, Statistical Process Control, PDCA, Value Stream Mapping, SOP, TQM, OEE, Change Control, Project ... - 2020 Oct 06

Industrial Engineer

Buffalo, NY, 14226
... S&OP, Procurement & strategic sourcing, Negotiation & contract management, Lean, Six sigma, PDCA, 5S, Kaizen, VSM, 8D, CAPA, SPC, Quality control EXPERIENCE Student Lean Consultant - Pro bono, 3-Pillars catering, Buffalo, US Jan 2020 - May 2020 • ... - 2020 Oct 04

Quality Engineering

Buffalo, NY
... Core Competencies Quality tools: Root-Cause Analysis, Statistical Process Control (SPC), 5 Why, 5S, 8D Problem-Solving, Corrective Action Preventive Action (CAPA) Production: Failure Mode and Effect Analysis (FMEA), Production Part Approval Process ... - 2020 Sep 23

Engineer Quality

Buffalo, NY
... • Resolved customer complaints, process failure risks through Failure Mode Effect Analysis (FMEA), CAPA, Root cause analysis, 5 why, 8D problem solving approach & Control plans. • Developed Quality levels with respect to APQP, SPC, validation, ... - 2020 Jul 25

Engineering Manufacturing Engineer

Buffalo, NY
... SKILLS: Lean Manufacturing, PFMEA, DMAIC, 5S, KPI, SOP, Continuous Improvement GD&T, BOM, DOE, GR&R, Kaizen, CAPA, Control Charts, SPC, Poke Yoke, Pareto Analysis, Cpk Analysis, QMS, Quality tools, ISO 9001:2015, PPAP, APQP, MSA SOFTWARE: SOLIDWORK, ... - 2020 Apr 03

Engineer Injection Molding

Buffalo, NY
... assigning items and holding team members • Managed cost projection, Timing plans, risk registers, FMEA's, control plans • Owned numerous projects of varying complexities and purposes (validation, CAPA, R&D, continuous improvement, etc) Engineering ... - 2019 Aug 13

Electrical Engineer

Niagara Falls, NY
... Industries: OEM Manufacturing, Aerospace and Defense, Industrial Power Design (MEP) Knowledge Base: QS 9000/ISO9001, Validation/IP, OP, QP, CAPA Systems / RCA, SMED, 5S, Lean, PM, PMBOK, PLC, NFPA 70E, NEC Engineering Skills: • Project / Program ... - 2019 Jun 10
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