Manager, Quality
Alajuela, Costa Rica
hace 23 días

JOB DESCRIPTION : Position Summary :

Position Summary :

This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation were product is distributed.

This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the plant’s leadership team and the appropriate Divisional Management Representative.

Qualifications :

  • Bachelor's degree in Engineering, Science or Technical Field, or Bachelor's degree in Business Administration with at least 7 years of experience in Quality Engineering roles.
  • 7+ years of experience.
  • Excellent English and communication skills required
  • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required
  • Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485
  • Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC)
  • Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment
  • Demonstrated organizational influence to include, but not limited to : compliance excellence, organizational improvement, product-
  • related risk mitigation, and / or manufacturing cost reduction

  • Ability to travel to support domestic and international manufacturing sites (up to 15%)
  • Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", acepto que neuvoo recolecte y procese mis datos de conformidad con lo establecido en su Política de privacidad . Tengo derecho a darme de baja o retirar mi autorización en cualquier momento.
    Formulario de postulación