Quality System Engineer
cardinal health
Alajuela, Alajuela, Costa Rica
hace 5 días
  • Assure compliance with regulations as ISO13485, JPAL, QSRs and others.
  • Manages and coordinates documentation control and training personnel.
  • Provide guidance and support for determining regulatory / compliance strategies to meet the requirements of established certified standards, regulations and customer requirements.
  • Support the various departments on compliance issues and CAPA investigations.
  • Act as Lead Auditor at the Site for Internal Audits. Plan and execute audits and ensures follow up as required to maintain ongoing Quality Compliance.
  • Assure Audit responses are completed on time and base on investigation requirements. Assist in providing input towards CAPAs.
  • Ensure that all documentation related to training and documentation control process has the appropriate format to interface with computer system used by Corporate.
  • Provides support related to My Learning System and Agile documentation system.
  • Manage and oversee new systems pertaining to the Training Requirements.
  • Supports Human Resources in all related activities to personnel induction
  • Coordinates with manufacturing the training of new operators, ensuring curricula’s are properly assigned to quarantine that personnel have the correct competencies to execute their activities
  • Qualifications

  • Bachelors degree in Industrial, Chemical, Mechanical Eng. or similar.
  • 2+ years medical device manufacturing experience, preferably in QA Engineering or QA technician.
  • Advance proficiency in English
  • Solid communication and writing skills.
  • Computer skills including statistical / data analysis (Excel, Minitab, etc).
  • Quality System Standards, GMPs and Regulations experience is desired.
  • Project Management, SPC, DOE, FMEA, CAPA, internal audits, process validations, complaints system, root cause analysis, risk analysis techniques, capability studies knowledge is desired.
  • ASQ CQE certification is desired.
  • Previous training and document control experience is highly desired.
  • What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes actions to resolve
  • Applies judgment within defined parameters
  • Receives general guidance may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy
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