Ingeniero de Calidad
cardinal health
Alajuela, Alajuela, Costa Rica
hace 4 días

What Quality Engineering contributes to Cardinal Health

Quality Engineering is responsible for product and service quality planning, evaluation, and control. Works cross-functionally in the development and implementation of prevention-based methodologies used in design, manufacturer, test, sustainability and correction of products and services.

This role will be accountable of quality activities related to the product during manufacturing, once it leaves the production line and manufacturing site, as well as during post market surveillance.

The QA Engr will liaise with various departments across the organization to ensure product quality in the areas of product design, risk management, manufacturing, packaging, sterilization, and shipment and delivery to our distribution centers.

Accountabilities

  • Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
  • Develops and implements quality programs and process improvement initiatives to ensure compliance of final product quality standards and delivery.
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
  • Acquires and analyzes data using appropriate standard quantitative, statistical methods to facilitate process analysis and improvements.
  • Understands product design, design transfers, and production line quality standards, i.e., controls, process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
  • Demonstrates knowledge of reliability, maintainability, and product risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
  • Experience with performing process validations (IQ / OQ / PQ), equipment qualification, and test method validations.
  • Strong communication skills (written and verbal); ability to present communication plans and status updates to customers
  • Qualifications

  • Bachelor’s Degree in Engineering, Quality Assurance or related subject matter or equivalent work experience preferred
  • 4+ years’ experience in medical device manufacturing environment
  • Advance proficiency in English and Spanish.
  • Demonstrated knowledge of medical device and governmental regulations and standards (21 CFR Part 820, ISO13485, MDR).
  • Demonstrated knowledge and experience with FDA’s product Design Control process and design / product transfers.
  • Strong understanding of statistics, statistical theory, and statistical analysis
  • Strong understanding of business unit function and cross group dependencies / relationships.
  • Solid ability to easily create partnerships with internal customers.
  • Self-starter, proactive, adaptable, and engaging approach.
  • Black belt, Lead Auditor for medical devices or Certified as Quality Engineer preferred
  • Experience in project management and 6 Sigma process improvement methodologies preferred.
  • 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
  • Exercises judgement in selecting innovative, practical methods to achieve problem resolution.
  • May lead a project team. Participates in determining goals and objectives for projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes actions to resolve
  • Influences management on technical or business solutions.
  • Applies judgment within defined parameters
  • Plans and organizes non-routine tasks and establishes priorities of work assignments with approval. Receives general guidance may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy
  • May provide work direction and guidance to exempt and / or skilled nonexempt levels of employees.
  • Ability to present project status by preparing standard status report and by participating in departmental and customer project update meetings.
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