Quality Engineer ll

hace 1 semana

Alajuela, Alajuela, Costa Rica Theragenics A tiempo completo

PURPOSE OF JOB:
Responsible for establishing and improving quality assurance practices and procedures; evaluation of quality sampling plans and inspection methods and reviews/recommends solutions to quality problems.

Additionally, this position is responsible to Develop, implement, maintain and improve appropriate quality system elements to ensure the high quality level of existing products and as well new products transferred to the Site.

RESPONSABILITIES:

  • Lead and/or support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.). Execute equipment and process validation activities as required
  • Review and ensure validation protocols as well as monitor quality policies regarding the transfer and validation processes of processes/products
  • Provide manufacturing on-the-line Quality support
  • Investigate instances of nonconforming material and facilitate the determination of root cause, correction action/preventive action (internal &supplier), and recommendation of disposition (Material Review Board)
  • Write procedures necessary for implementing quality requirements
  • Utilizes DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA)related activities, including CAPA ownership if appropriate
  • Design means for measuring accuracy and documenting of inspection work
  • Evaluate and recommend inspection gauges and test equipment
  • Evaluate incoming raw material acceptance plans for effectiveness and validity
  • Participate with manufacturing to recommend in-process and final inspection strategies to assure product quality at each stage of manufacturing
  • Ensure appropriate use of sampling plans and evaluate statistical rationale of acceptance plans at all stages of design and manufacturing
  • Audit processes, internal and supplier, for quality and regulatory compliance and recommends improvements based on analysis of data and system performance
  • Collaborate with suppliers to ensure the quality of incoming materials and components
  • Develop key indices of measurements for quality, cost and delivery and improve cycle times
  • Leads or assists in process improvement projects and provides technical input and assistance in activities such as Quality planning, Risk analysis, FMEA
  • Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other QA engineering areas (once he obtains Minitab training and ASQ certification)
  • Write, review and performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols

Requirements
EDUCATION:

  • Bachelor's degree from four-year college, university, or 4 years related experience, and/or training or equivalent combination of education and experience. Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements
  • ASQ CQE/CSSBB is considered a plus
  • English 85%

EXPERIENCE:

  • Previous experience in Quality in a regulated industry, 2-3 years specifically in a medical device environment
  • Hands-on experience in validation activities, including process validation, equipment qualification, and protocol development
  • Preferred: Knowledge of statistical analysis tools and familiarity with equipment and process validation
  • Familiarity with Minitab or any equivalent statistical tool is required

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