CAPA Manager

Published: June 3, 2020
West Region, Puerto Rico
Job Type
Job Code
Years of Experience
Commensurate with Candidate Experience
Bachelor’s Degree
Ilia Cordero
Contact Email



  • Implement NC/CAPA Program governance and sustain.
  • Ensure compliance with specifications, SOPs, GMPs, ISO standards and any other applicable regulatory requirements.
  • Recommend & execute NC/CAPA process improvement projects.
  • Ensure NC/CAPA key performance indicators compliance. Monitor other investigations related to complaint.
  • Serve as resident expert in NC/CAPA regulatory/compliance.
  • Monitor and trend information related to root cause analysis, corrections, corrective and preventive actions, and tracking of timelines.
  • Monitor effectivity of the CAPA System.
  • Coordinate NC/CAPA weekly governance meetings and act as advisor on adequate root cause analysis, CAPA plan and effectiveness checks.
  • Assist/interface with NC/CAPA owners on investigations and action plans.
  • Conduct training on root cause analysis and problem-solving techniques.


  • Bachelor’s degree required, preferably with an education background in science, engineering, manufacturing.
  • Minimum 5 years of experience technical writing and/or procedure development, in medical device, pharmaceutical, or another FDA regulated environment
  • Knowledge of Pharmaceutical and Medical Device regulations, statistical sampling and analysis.
  • Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • Seven to ten years minimum work experience in regulated industry.
  • 5 years minimum managing CAPA Quality System.
  • Exposition/experience managing Regulatory agencies external audits desired.
  • Familiarity with requirements for regulatory submissions and guidelines for pharmaceuticals, biologics, and medical devices.
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings to include 510(k), IMPD, INDs, MAAs NDAs, and BLAs.
  • Knowledgeable of applicable FDA regulations and ISO Standards: 21 CFR 211/ 820 ISO 13485 and ISO 14971 and EU Medical Device Directive.
  • Knowledge in laboratory, critical systems and manufacturing quality operation areas.
  • Knowledge of problem-solving techniques, Process & Risk Management.
  • Strong Leadership and Analytical Skills.
  • Experience in managing FDA Audits.
  • Requires advanced critical thinking and technical writing skills
  • Good organizational, communication, and interpersonal skills are necessary, understanding of Quality process.
  • Communicating effectively in writing as appropriate to the audience.
  • Knowledge on Word, Visio, Excel, and other electronic systems to complete tasks.
  • Strong prioritization and multitasking skills.
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