Engineer Iii, QA - Tijuana, México - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Empresa verificada
Tijuana, México

hace 1 mes

Rodrigo Fernández

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee
Descripción

Summary:

Coordinates subordinates in the inspection and/or receiving testing and/or process and finished products, according to established procedures.


Responsibilities:


  • Participates/Leads CAPA investigations.
  • Evaluate and makes analysis of samples received from customers related to Customer Complaints.
  • Perform investigations and action plans related to the customer complaints and CAPAs.
  • Works with a multidisciplinary team to identify the root cause of problems, define the necessary actions required to assure corrective and preventative actions are properly implemented and documented.
  • Ensure that Corrective and Preventive Actions implemented have been effectives.
  • Participate in the process and product improvement plans.
  • Participates actively in cost reduction and PPI projects.
  • Gives support to Quality Assurance & Quality Manager to participate in external audits and support in audit observations (ISO 9001 and ISO 13485 environment)
  • Coordinates the initiation and closure of internal non conformances (NCMs). Uses of Trackwise System for this process.
  • Works in the Root Cause Analysis for NCM in the production area.
  • Participates/Leads internal audits.
  • May participate in the Management Review as presenter on its area.
  • Conducts trend analysis and post activities related when a trend is presented.
  • Originator of Document and Change Control DCOs, ECOs, ECR etc. Uses of Agile System
  • Originator of Deviations if need it using Trackwise System.
  • Close relationship with the Quality Supervisor for activities related to product requirements.
  • Create/perform pFMEAs and updates as needed (ISO
  • Develop quality requirements based on drawing and customer requirements.
  • As need it, will create or update work instructions WIN, procedures SOP, visual aids, FRM, formats, Internal Quality Alerts related to its area.
  • Create Protocols and perform Test Method Validations, process validations quality matter.
  • Works to achieve Quality KPEs and Quality Objectives.
  • Participates/Leads new projects.
  • Other duties may be assigned, as required.

Education:


  • Bachelor's degree in Engineering or Science or equivalent training and /or experience, with focus on Biochemicals, Industrial Engineering and/or Quality Engineering.
  • Internal auditor desirable
  • Six Sigma desirable
  • ASQ Certifications desirable

Experience:


  • 5+ year of experience as Quality Engineering.
  • Injection Molding.
  • Knowledge: ISO 13485, 21 CFR part 820. (Medical Devices Industry)
  • Software Systems related, such as Agile, Trackwise, Macola (desirable)
  • Applications of Statistics, Minitab
  • Measurement instruments as calipers, micrometers, Vision optical.
  • Knowledge of Lean manufacturing process.
  • Handson experience in CAPA Process.
  • Experience with problemsolving techniques such as Fishbone diagram, 8 Step-Method, etc.

Languages:
English Level
:90 %
minimum (Written and Speaking)**
Skills:
  • Strong Problem
  • solving skills and statistical data analysis
  • Personality: Creative, Responsible, Cooperative, and Dynamic.
  • Strong leadership and team management skills.
  • Strong computer skills including Microsoft Office with a focus MS Excel, use of software systems (Agile, Trackwise, Macola).
  • Highly Ability to write reports/protocols.
  • Ability to interpret drawing requirements and tolerances.
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