Manager I, QAPD JobManager I, QAPD Job
Boston Scientific Corporation
Coyol, A, CR
hace 8 días

Additional Locations : Purpose and Passion

Purpose and Passion

  • Comprehensive Benefits
  • Career Growth
  • At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.

    With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.

    Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.

    About the Role :

    Your Responsibilities Include :

  • Plan, coordinate and execute projects oriented towards process defects prevention and overall quality improvement.
  • 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 Quality area and to other departments.
  • Coordinate Quality Engineering functions and activities.
  • Deliver training related to quality technologies.
  • Coordinate with Corporation the implementation of projects related to the Quality dpt.
  • Create new procedures 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 : 803.
  • 5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.

    65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.

    100 CAPA, 820.198 Complaint Files.

  • Provide support to new products / process transfer projects
  • May design and implement process control strategies.
  • May facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
  • May 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 : tracking and keeping NCEP investigations related to the area closed;
  • area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.

  • May participate in the PIR (Product Inquiry Report) process, assuring : diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation.
  • May act as the Quality Director (Head of Quality) designee in PIR process activities.

  • 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’re Looking For :

  • Academical Degree in Licenciature Industrial Engineer or field Related.
  • English Level required : C1 : 90-94%
  • Desired knowledge : Formal training on statistical and quality techniques desirable, desirables ASQ Certified, Knowledge of six sigma, lean, APQP or similar tools.
  • At least 7 years of experience in similar position.
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