Manager I, Quality Systems
Boston Scientific
Heredia, H, CR
hace 7 días
source : Successfactors

About thisrole

Responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site s manufacturing processes.

Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs.

Additionally, he / she is responsible for planning and supervising In Process Quality Engineers functions and activities.

Your responsibilities will include :

  • Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.
  • Provide support to new products / process transfer projects; review risk analysis (PFMEA) for the different processes.
  • Plan, coordinate and execute projects oriented towards in process defects prevention.
  • Design and implement process control strategies.
  • Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
  • Review and / or approval of documents, investigations, extensions or another regulatory figure within the company s quality system, as an alternate representative of Quality Management.
  • Provide technical support to the In Process Quality area and to other departments.
  • Deliver training related to quality technologies.
  • Coordinate with Corporation the implementation of projects related to the In Process Quality area.
  • Create new procedures on In Process Quality and / or improve the existing in order to facilitate and assure regulatory compliance.
  • Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company s quality system : Individual Adverse Event reports, 70 Production and Process Controls, Process Validation, Identification, Traceability, Inspection, measuring and test equipment, Non-
  • conforming product, Receiving, in-process and finished device acceptance, CAPA, Complaint Files.

  • Participate as a core team member in the new products transfer process, representing Quality Assurance areas.
  • May act as NCEP System administrator for the area.
  • Participate in the PIR (Product Inquiry Report) process.
  • May provide guidance and supervision to process validation areas, software validation complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and / or design assurance.
  • What we are looking for :

  • LicenciatureIndustrial, Electronic, Biotechnology, Electromechanical Engineering or related field
  • 10 years experience
  • 90% English
  • Master Degree desirable
  • Free Zone Trade and national and internacional laws knowledge
  • ASQ Certification will be a plus
  • Knowledge of Six Sigma, Lean, APQP or similar tools
  • Amarilis Plaza

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