Quality Director (QARA)
Pall Corporation - Fajardo, PR

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Responsible to maintain comprehensive, cost-effective, and progressive quality standards for the plant products of all Pall LS Global Filter. Activities typically include reviewing designs/plans of proposed new products; developing procedures that economically maximize quality standards; establishing and directing laboratory facilities for quality testing of raw materials, finished goods, and goods in process. Develops strategies and implement programs to assure regulatory compliance and standards of quality. Provides leadership in responding to FDA trends and GMP requirements. Manages GMP compliance audit programs. Executes control over all or some of the following programs/systems: the change control system, documentation control, product complaint investigation and analysis.

Required Skills
  • Good oral and written communication skills (English and Spanish).
  • Strong knowledge of domestic regulations (FDA-QSR) and ISO 9000 international standards, including Japanese and Canadian regulatory systems.
  • Strong analytical, numerical, and reasoning abilities.
  • Ability to establish credibility and be decisive
  • Results oriented with the ability to balance other business considerations.
  • Proven ability to recruit, train, and motivate personnel
  • Ability to prepare and operate within projected functions budgets.
  • CQE, CQM, CQA, Six Sigma, ISO Lead Assessor certifications are a plus.
  • Excellent interpersonal and communication skills.
Computer literate

Required Experience
  • Bachelor’s Degree or Master’s Degree preferred.
  • Minimum ten (10) years of significant manufacturing experience in GMP and regulatory compliance activities within the pharmaceutical or medical device industry.

About this company
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With operations around the globe, Pall is not small. The company operates two businesses globally: Life Sciences and Industrial. The Life...