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Online Resumes with "CAPA Processing"
A Quality Professional from Creation to Certification
Outstanding Quality Professional with exceptional interpersonal, communication, and leadership skills. Able to work under very challanging conditions that a start-up company contains.
Ideal Companies: Boston Scientific, General Electric, any start-up company in the medical field
Tags for this Online Resume: Quality
Quality Manager - 11 years experience - Medical Device - ISO 9000, ISO13485, GMP, FDA
Continue to help companies maintain or create a constantly improving quality system.
Tags for this Online Resume: Quality Manager, Manage Internal, External and Supplier Audit Program, • Management liaison with all customer, third party and FDA auditors., CAPA / Process Improvement, Process Improvement, Document Control Specialist
Senior Quality Assurance / Labeling (Regulatory Compliance) Manager
I'm an Senior Manager / Director level professional with 17+ years' experience in medical device labeling, regulatory compliance, risk analysis, quality systems/CAPA, and process engineering. I regularly am enrolled in classes at Stanford University and enjoy other forms of professional development; see my profile at www.linkedin.com/in/aimeecampbell
Tags for this Online Resume: labeling, quality, FDA, CAPA, device, process engineering, translation, MDD, Health Canada, Menlo Park, SF Peninsula, San Francisco, manager, project, EU, DMR, Risk, DHF, analysis, implementation, operations, Director, team, leader
PM Medical Devices - 10 Years of Experience
Develop best in class next generation medical devices for global countries.
Ideal Companies: Apple, St. Jude, Stryker, BD, Covidien, Google
Tags for this Online Resume: Mechanical Engineer, Medical Devices, Project management, Program Management, Portfolio Management
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
Quality Engineer - 20 Years of Experience - Near 27509
SUMMARY OF QUALIFICATIONS Well practiced at conversing with the end-customers to provide them with satisfaction. Knowledgeable in achieving the ISO 9000 requirements within the manufacturing process. Authority of all aspects of the PCBA assembly (SMT, Thru-Hole) in the manufacturing process. Accomplished in interpreting IPC Workmanship requirements. Advanced experience level in performing the 8D CAPA process. Box-Build asse...
Tags for this Online Resume: Management, Quality Assurance, Manufacturing, Automotive, Quality, Integrate, Distribution, Documentation, Equity
Quality Assurance Director - 3 Years of Experience - Near 94566
Walter holds a Master's Degree in Systems Management and a Bachelor's Degree in Industrial Engineering/ Quality Engineering. Walter is a Six Sigma Lean, Black Belt. He has extensive years of experience as Director and Senior Manager positions in Quality and Operations positions for Bio-Tech, Pharmaceutical and Medical Device industries. He has hands on experience in Project Management, Design Control Pre-Market, Post Market...
Tags for this Online Resume: Management, ISO, Compliance, Documentation, Risk Assessment, Audit, Manufacturing, Project Management, Project Manager, Risk Management, Quality Systems Professional
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
In Between - 15 Years of Experience - Near 27572
QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Developme...
Tags for this Online Resume: Training, Corrective Actions, Data Processing, Good Manufacturing Practices, Manufacturing, Quality Assurance, Test, Data Entry, Document Management, Filing
Compliance Manager
Professional Summary Competent, innovative, and forward-thinking management professional with extensive experience in advanced technology manufacturing environments and a proven track record of sustaining productive, high quality and cost-conscious production operations for mid-size and major corporations. Recognized for a thorough understanding of all processes, methods, procedures, equipment and materials used in high-tec...
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), Audit, Compliance, Data Entry, Enterprise Software, ESS, Failure Analysis, ISO, Microsoft
Clinical Quality Assurance - 15 Years of Experience - Near 33175
Qualifications Summary Exceptionally organized, detail-oriented, and outcome-focused professional, aiming to pursue a career opportunity that would require exceptional competencies in research, program development, and biological sciences. Enthusiastic to apply extensive research, critical thinking, and communication skills in a variety of scientific and research functions within the biotechnology environments. Versatile in...
Ideal Companies: Becton Dickinson, Amgen, Beckman Coulter
Tags for this Online Resume: Chemistry, Programming, ELISA, Robotics, Quality, Quality Assurance, Test, trial, phase, clinical, pharmaceutical, CAPA, Field Actions, Lean Procces, DBS
