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Distance: Resume alert Resumes 231 - 240 of 7109

Regulatory Affairs Specialist with Medical Device Focus

West Roxbury, MA
... SKILLS Regulatory & Quality Systems: FDA 510(k), PMA, IND/NDA/BLA/ANDA, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, ICH Guidelines, Clinical Trial Regulation, PMS, CAPA, Root Cause Analysis, QSR Audits, Global Policy Monitoring (FDA, EMA, PMDA, APAC, ... - 2025 Nov 24

Supplier Quality Engineer global

Illinois
... attempt PPAP, APQP, FPA acceptance record Support Sigma Tron Medical device division located union city in internal and external CAPA as team leader -involves root cause analysis, action plan to prevent defects Worked on permanent 8-D preventative ... - 2025 Nov 24

Manufacturing Process Engineer Pharma, Aerospace, Medical Devices

Anaheim, CA
... Time to Work divided by Customer Demands will give piece work time (min/piece) Setup of Lab Equipment periodic reviews including calibration and specifications updates Investigated equipment for a Process Deviation and generated CAPA reports. ... - 2025 Nov 24

Quality Management Leader with 18 Years Experience

Tabuk, Saudi Arabia
... Proven track record of delivering quality excellence, improving Project Quality Index (PQI) to 90%+, embedding risk-based methodologies (FMEA, RCA, CAPA), and leading organization-wide quality transformation initiatives. Skilled in multidisciplinary ... - 2025 Nov 22

Quality & Supply Chain Leader with 16+ Years

United States
... CORE COMPETENCIES • Manual QA Testing Leadership • QA Strategy Development & Ownership • Regression, Integration & Performance Testing • SDLC, Agile QA Integration • Documentation, SOPs & CAPA • Defect and Recall Reporting & Root Cause Analysis • ... - 2025 Nov 21

Senior Technical Writer and Documentation Leader

San Antonio, TX
... 3M (formally, Acelity / KCI) Designed MS Word test document templates that are compliant with regulatory standards and resilient to audit scrutiny by the Federal Drug Administration (FDA) using Corrective and Preventative Action (CAPA) initiatives ... - 2025 Nov 21

Principal Quality Engineer - Regulated Manufacturing & Compliance

Marietta, GA, 30064
... CORE COMPETENCIES Quality Management Systems Software Quality Assurance Design Controls GMP & GDP Compliance CAPA & Root Cause Analysis Supplier Audits & Risk Management SPC & Process Validation Continuous Improvement Cross-functional Leadership ... - 2025 Nov 21

Senior Scientist - Formulation & Quality Leadership

Toledo, OH
... Core Competencies Product Development: Formula creation, bench to scale-up, stability testing, technology transfer, formulation optimization, new product development Quality Assurance: Quality control, compliance validation, CAPA implementation, ... - 2025 Nov 21

Regulatory Affairs & Compliance Specialist Resume

Pawtucket, RI
... • Collaborated with cross-functional teams (Quality, Operations, Engineering) to implement CAPA tracking systems and support manufacturing process improvements. • Analyzed quality and compliance data using statistical tools (Excel, Tableau) to ... - 2025 Nov 20

Customer Service Leader - Remote Team Management - Process Improvement

Dracut, MA
KIMBERLEE HOWELL CONTACT INFO *******@*****.*** 617-***-**** Dracut, 01826, United States https://www.linkedin.com/in/kimbe rlee-howell EDUCATION Trinity College September 1986 - June 1988 SKILLS Quality Assurance, Auditing, CAPA Kronos, ADP ... - 2025 Nov 20
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