Quality Section Leader

Abbott

  • Alajuela
  • Permanente
  • Tiempo completo
  • Hace 1 mes
JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The OpportunityThis position works out of our Costa Rica – Alajuela location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Quality Section Leader, you will be 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.What You’ll Do
  • Management and development of Quality Engineers and Technicians.
  • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
  • Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
  • Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
  • Define and implement Process Control & Monitoring systems.
Provide influential peer leadership with international partner site to drive proactive quality improvements.
  • Identify Quality Initiatives and lead cross-functional teams to complete them.
  • Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
Required Qualifications
  • Bachelor’s Degree Engineering, Science or Technical Field, or Bachelor's degree in Business Administration.
  • 5 to 7 years of experience with preferably 4+ years in a quality engineering roles.
  • 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.
  • Bilingual English /Spanish (required).
SHIFT C: Monday - Friday 10:00 pm - 06:00am.Works 100% On sitePreferred Qualifications
  • 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
  • FDA Class II or Class III medical device experience.
  • Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CRE/CQM).
  • Desired previous experience in NPIs.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EP ElectrophysiologyLOCATION: Costa Rica
Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2ADDITIONAL LOCATIONS:WORK SHIFT: Crshic36 (Costa Rica)TRAVEL: Not specifiedMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment

Abbott