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Online Resumes with "ISO 14971"

Industrial Engineer

Tags for this Online Resume: Lean, Six Sigma, Quality Management, ISO 9001, ISO 13485, ISO 14971

Featured Profile

Design Assurance, Regulatory Compliance - medical device

Tags for this Online Resume: ISO 13485, ISO 14971, ISO 9001, Engineering , MDD Harmonized Standards, CE Marking

Product Complaints Specialist

Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills

Ideal Companies: Biomedical, Biotechnology, Healthcare compliance

Tags for this Online Resume: compliance, Regulatory


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

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

Biomedical Engineer - 2 Years of Experience - Dallas

SUMMARY: Biomedical Engineering graduate student with a specialization on Medical Imaging and Instrumentation. Hands on experience in operating complex medical equipment and expertise in image processing. IISE Certified Six Sigma Green Belt. Knowledge of ISO 14971, ISO 13485 and FDA regulations. Independent researcher, Dedicated, Self-Driven, Self-Motivated, Result Oriented, Team Player, Detail Oriented, and a Quick Learner.

Tags for this Online Resume: Data Analysis, Matlab, Biomedical Industry, C Programming Language, C++ Programming Language, Connectivity, Engineering, Green Belt, Image Processing, Imaging

Engineer - 19 Years of Experience - Near 33184

Tags for this Online Resume: Audit, Product Development, Risk Analysis, Software, Software Development, Support, Technical Support, Test, Documentation, Quality, Validation, Verification, Human FActor, CAPA, ISO 14971:2012, GMP, 21CFR Part 11, SPC, Post Launch Risk Assesment

Quality Manager - 20 Years of Experience - Near 30152

Known as a Quality and Operations Leader for improving business results and promoting the quality approach to doing business by example. I believe everyone has a customer and a supplier regardless of their function in the organization. * Led the effort at both Ampac and Printpack in developing and implementing a corporate-wide management system based on the ISO 9001 ISO 13485 ISO 14971 ISO 11607 as well as other FDA EU and ...

Tags for this Online Resume: Pharmaceutical, Manufacturing, Management, Process Improvement, ISO 9001, Product Development, Purchasing, Continuous Improvement, Quality Assurance, ISO 13485, Lean Methods, Six-Sigma, Corrective Action, CAPA, Root Cause Analysis, Package Manufacturing, Quality Management, Training Management

Risk Management - 19 Years of Experience - Near 01845

FAMILIARITY WITH: ISO 1009, ISO 10993, ISO 13485, ISO 14969, ISO 14971, ISO 24971, 21 CFR Part 11, 21 CFR Part 820, IEC 62355-1, and HIPPA.

Tags for this Online Resume: Test, Test Plans, Quality, Unix, C++ Programming Language, C/C++ Programming Languages, Java Programming Language, Management, Quality Assurance, Software

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 53143

Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...

Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices

Quality Manager - 17 Years of Experience - Near 60051

SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...

Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management