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Medical device Quality Engineer

Takoma Park, MD
... testing, Supplier Quality/Vendor Assessment, CAPA process, investigations & remediation, GMP, Safety & Effectiveness testing, internal auditing and mitigation, Risk Management/ FMEA (ISO 14971), complaints/failure analysis, product improvement. ... - 2025 Jun 06

Business Analyst, IT Manager

Greenfield, MN
... • Systems validation, QA, and CAPA, CCM/BPI team member, FDA & SOX compliance. • Administrator for HP Device Manager, Altiris Deployment Server w/1000+ manufacturing HP thin clients used in Manufacturing Execution System (MES), Global Labeling ... - 2025 Jun 06

Quality Engineer Lead

Springtown, TX
... AD – Tech Medical Instrument, Oak Creek, WI (Medical Device contract manufacturer) CAPA Quality Engineer (contract) July 2019 – October 2019 Investigated root causes, recommended corrective and preventive actions to multi-level CAPAs. Investigations ... - 2025 Jun 05

Product Development R D

Irvine, CA
... Skilled in Design of Experiments (DOE), statistical analysis using Minitab, and technical documentation, I have also supported CAPA, and audit readiness processes. Additionally, I hold several patents and have contributed to the development of ... - 2025 Jun 05

Quality Control Assurance

San Jose, CA
... - Working experience to initial for trouble shooting, Root cause Analysis and assist for CAPA. - Working experience for Electromechanically parts assemblies. - WORK EXPERIENCE: Senior Quality Inspector – Cytek Biosciences -Fremont, CA (Jan.2021-Jan ... - 2025 Jun 05

ISTQB certified QA tester

Garner, NC
... Proven ability to manage QA processes across the SDLC, including verification, validation, CAPA, risk management, and regulatory compliance (GMP, FDA, ISO 13485). Adept in Agile and Waterfall methodologies, with hands-on testing and documentation ... - 2025 Jun 04

C# Software Engineering

San Diego, CA
... ●Quality Assurance: Software Verification & Validation (V&V), Design Control (FDA QSR, ISO 13485, IEC 62304), SOP & Quality Documentation Authoring, CAPA, Non-Conformance Management, Post-Market Surveillance, Audit Support (Internal, FDA, Notified ... - 2025 Jun 04

Quality Control Lab Assistant

Oakland, CA
... LEADERSHIP & ACTIVITIES President, USD Pre-Vet Club Fall 2024 - May 2025 Filipino Ugnayan Student Organization (FUSO) Fall 2022 - May 2025 CEA CAPA Study Abroad Ambassador September 2023 - December 2024 Co-Vice President & Secretary, USD Pre-Vet ... - 2025 Jun 04

Lead Auditor Quality Assurance

Karur, Tamil Nadu, India
... SKILLS • BIS Audit Compliance • ISO 9001/14001/45001 • PPAP Documentation • Risk Assessment • Supplier Quality Audits • Quality Assurance • 8D & 5S approach • CAPA • HRM & Conflict management • H&S implementation CERTIFICATIONS ISO 22000 LEAD ... - 2025 Jun 03

Technical Writer Change Management

Northville Township, MI, 48152
... Performed meticulous validation document audits, ensuring accurate data records, valid signatures, and highlighting any possible regulatory risks per CAPA for an effective quality management system. Technical Writer, 05/2018 - 05/2019 Thermo Fisher ... - 2025 Jun 03
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