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Online Resumes with "Capa"



Department Manager - 17 Years of Experience - Near 61104

PROFESSIONAL SUMMARY Self-motivated, dedicated and reliable professional with proven experience as packaging mechanic, supervisor, lead technician and technical trainer solid experience with multiple operating systems. Supervior: Lead Technician: Provide troubleshooting expertise, preventive maintenance and repair of integrated packaging lines in a cGMP environment ensure compliance with standard operating procedures (SOP)....

Tags for this Online Resume: maint, Preventive Maintenance, Leadership, Packaging, Reliability, Management, Pharmaceutical, Project Management, Support, maintenance

Department Supervisor maintenance - 17 Years of Experience - Near 61104

PROFESSIONAL SUMMARY Self-motivated, dedicated and reliable professional with proven experience as packaging mechanic, supervisor, lead technician and technical trainer solid experience with multiple operating systems. Supervior: Lead Technician: Provide troubleshooting expertise, preventive maintenance and repair of integrated packaging lines in a cGMP environment ensure compliance with standard operating procedures (SOP)....

Tags for this Online Resume: Preventive Maintenance, Leadership, Packaging, Reliability, Management, Pharmaceutical, Project Management, Support, Training, Troubleshooting, maintenance

Biomedical Engineer - 14 Years of Experience - Near 92563

Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...

Tags for this Online Resume: ISO, Acceptance Testing, Account Manager, Integrate, Logistics, Manufacturing, Services, Test, Assessments, Critical Care - Vascular, electronics, Metrology

Quality Manager - 20 Years of Experience - Near 92688

Certified Quality Assurance Director with a successful 27 year career in a leading Aerospace, Aviation and Defense industry. Extremely resourceful and self-starter individual with strong analytical, technical and engineering expertise with critical structural and avionics aircraft component design and manufacturing, combined with a wide knowledge of Quality System regulations and QMS implementation support to ISO-9001-2008,...

Tags for this Online Resume: Certified Six Sigma Green belt, Process Improvement, PPAP, SPC, RCCA, CAPA, Project Management, Strategic Planning, Quality Assurance, Test, manufacturing, mechanical engineer, "project management", reliability

validation/quality/manufacturing engineer

PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...

Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing

Operations Director - 20 Years of Experience - Near 92887

Seasoned operations leader and culture expert with over 15 years of increasingly responsible management experience, most recently in the pharmaceutical industry. Expertise includes improving operational efficiency and creating an environment where top-notch employees are mentored and appreciated, thus reducing employee turnover. Strong CAPA experience and Lean Six Sigma Yellow Belt Certification. BA degree.

Tags for this Online Resume: Budgeting, Business Development, Management, Performance Management, Project Management, Pharmaceuticals, Manufacturing, Sales, Marketing, P&L, Mentoring, Performance Improvement, TrackWise, Publishing, Training, Technical Writing, Editing, Desktop Publishing, Team Building, Leadership, Strategic Planning, Auditing, Regulatory Compliance

Supervisor of Training and Document Compliance

ACCOMPLISHMENTS * Although I work well within a team, I am also self-supervised * Streamlined multiple Quality System processes including: Change Control, Engineering Change Control, Internal Auditing, CAPA (Corrective Action-Preventive Action), Supplier Approval, Maintaining Standard Operating Procedures (Included step by step instructions on how to use electronic document repository-Master Control), Training Program (Incl...

Tags for this Online Resume: Documentation, Compliance, SAP, Facilitator, OSHA, Policies and Procedures, Quality, Quality Assurance, Quality Control, Training, production, manufacturing, machine operator

military support-quality-20+yrs

QUALIFICATIONS SUMMARY: Diversified energetic and motivated professional of disciplines in Manufacturing, Production, Aerospace, Quality and Logistics. Experienced and talented in technical disciplines ranging from ferrous and non-ferrous forgings, to labs and clean room electronic component assembly. Experience includes automated systems, CNC equipment, maintenance theory, application and techniques, GD&T, hydraulic, pneum...

Tags for this Online Resume: Acquisitions, Aerospace, Aerospace Systems, Applications, APQP, Attention to Detail, Audit, quality, "project management", reliability, supplier quality, continuous improvement, military, weapons systems, lean, solutions, troubleshooting

Electrical Engineer

SUMMARY: Multidisciplined Electrical Engineering background with wide experience in Product Safety and EMC/EMI compliance procedures and tests Design, Research, Testing, System development, integration and implementation, Product and Quality Systems Certification ( ISO 9001/9002, ISO17025, ISO 13485), analysis and considerations of corrective and preventative actions (CAPA) for Electrical, RF, Telecommunications and Medical...

Tags for this Online Resume: Electronics, Research, Siemens, Systems Analysis, Xerox, Integrate, Quality, Test, ANSI, Ansi (Am Natl Stds Inst)

Microbiologist

A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...

Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management

Quality Manager

CAREER SUMMARY Ethical, strategic, and transformational leader who engages teams to deliver business results and drive sustainable excellence. Engineering Professional/Lean Six Sigma Black Belt with over 20 years + of experience in Quality, Supplier Quality, Process Engineering, and Kaizen/Lean Manufacturing in Food MFG/HACCP., Good Manufacturing Practices (GMPs), Vertical Pump Application, Global Drive Systems, elevators, ...

Tags for this Online Resume: Process Control, Management, SPC, ISO, Policies and Procedures, Project Management, Project Manager, Quality, Quality Assurance, Quality Management

Quality Manager

ACCOMPLISHMENTS * Although I work well within a team, I am also self-supervised * Streamlined multiple Quality System processes including: Change Control, Engineering Change Control, Internal Auditing, CAPA (Corrective Action-Preventive Action), Supplier Approval, Maintaining Standard Operating Procedures (Included step by step instructions on how to use electronic document repository-Master Control), Training Program (Incl...

Ideal Companies: RAI

Tags for this Online Resume: Documentation, Compliance, SAP, Facilitator, OSHA, Policies and Procedures, Quality, Quality Assurance, Quality Control, Training