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Online Resumes with "Part 820"

FDA compliance consultant

Started as a research assistant for a company that markets specialty clay for additives in polymers. Was listed as inventor on three patents. After a short assignment at a food company, moved into validation and quality work in the pharmaceutical industry.

Ideal Companies: Abbott, Baxter, Takeda, Hospira

Tags for this Online Resume: validation, cGMP, 21 CFR part 11, Part 820

Quality On My Mind

Experienced Quality profession dedicated to designing and implementing profit-centric Quality solutions

Ideal Companies: Alcon Labs, Boeing Inc., ASRC, Bayer

Tags for this Online Resume: Quality, Project Management, Software Validation, Product Validation, Corrective Action, Root Cause Analysis, Auditing, Public Speaking

Biomedical Engineer

An innovative leader with a diverse set of business and engineering expertise to successfully manage design & development of marketable products. A team builder & great communicator with diversified biomechanical engineering product design, development and manufacturing experience including hands-on engineering research on cell –based & synthetic bone substitute materials, design and manufacturing of cutting edge class II &...

Quality Engineer-10 years experience-ISO13485-21 CFR Part 820

Tags for this Online Resume: Deviations, QMS Documentation, Customer Complaints, Quality Plans, CAPA, Risk Assessment


I have 14 years of experience in pharmaceutical industries. Results oriented individual with a track record of instituting and maintaining high levels of Quality Assurance and leadership. I’m seeking additional opportunities for professional development in consulting, validation, compliance or technical areas. Strong analytical and planning skills. Six Sigma Black Belt trained. Knowledge in FDA, cGMP, GLP, 21 CFR - Part 820...

Ideal Companies: Pharmaceuticals or food industries

Tags for this Online Resume: qa, validation, lims, qc

Aircraft Rigging Assembler

A fast track, highly motivated, team oriented technical professional with a strong background in implementing product transfer, new product introduction, new laboratory set up, and validation activities related to GMP PART 820, ISO13485 and FDA requirements. More than ten years new product quality engineering experience in device, pharmaceutical, R&D/Manufacturing environments, and four (4) years R&D experience with semicon...

Senior staff scientist / Program Manager

Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

Ideal Companies: medical device companies; adjunct college professor; education manager within a company

Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology

Engineer - 20 Years of Experience - Near 48237

Experienced Quality Engineer in the Medical device manufacturing. Maintaining QS,FDA and ISO 13485 regulated industry. Hands on experience on inspection and testing.

Tags for this Online Resume: CQE, Coordinate Measuring Machine, ISO 13485, 21 CFR Part 820, CAPA, Complaints, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000, Automation, Automotive, Consulting, Dialysis, Engineering, Internal Auditor, ISO, ISO 9000

Featured Profile

Chemist - 20 Years of Experience - Near 33411

I am a Quality Assurance professional with over thirty years of experience in Quality Assurance in the Pharmaceutical, Biotechnology and Medical Device Industry.

Ideal Companies: Medical Device or Pharmaceutical Companies

Tags for this Online Resume: Failure Investigation, Corrective Action, Preventive Action, Training, cGMP's, Florida, Auditing, pharmaceutical

Quality Manager - 15 Years of Experience - Near 55044

Tags for this Online Resume: Six Sigma Black Belt, Lean Manufacturing, Continuous Improvement, AS9100 and AS9102, FDA 21 CFR Part 820

Validation Consultant-18 years experience in cGMP regulated environment-Dallas, Georgia

Technically accomplished, results oriented professional with 17 years CFR Part 11and GAMP 5, Part 58, Parts 210 & 211, Part 600, 601,610, Part 1270, 1271and Part 820 cGMP regulated environment with 10 years working experience writing, developing and executing validation protocols, managing calibration programs, maintaining and upgrading automated systems in a cGMP environment. Creative Metrologist/Chemist/Biologist and (IQ,...

Quality Engineer - 14 Years of Experience - Near 91016

 Over14 years of in-depth experience in the pharmaceutical industry.  Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.  Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...