Quality Assurance Engineer II

hace 1 mes

Alajuela, Alajuela, Costa Rica Confluent Medical Technologies A tiempo completo

Job Title: Quality Assurance Engineer II

Job Summary:

Confluent Medical Technologies is a leading provider of innovative medical devices, and we are seeking a highly skilled Quality Assurance Engineer II to join our team in Costa Rica. As a Quality Assurance Engineer II, you will play a critical role in ensuring the quality and safety of our products, from design to delivery.

Key Responsibilities:

  • Develop, apply, revise, and maintain quality standards for processing materials and products.
  • Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Analyze reports and returned products, and recommend corrective action.
  • Respond to supplier correction action responses and determine if vendors need to receive SCARs.
  • Prepare documentation for inspection and testing procedures.
  • Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
  • Devises new approaches to problems encountered.
  • Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Independently performs most assignments with instructions as to the general results expected.
  • Receives technical guidance on unusual or medium complexity problems and supervisory approval on proposed plans for projects.
  • Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
  • Performs work which involves conventional engineering practice but may include a variety of medium complexity features.
  • Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
  • Responsible for the purchase of equipment that meets health, safety, and environmental standards set by the company.
  • Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
  • May technically supervise or coordinate the work of draftspersons, technicians, and others who assist in specific assignments.
  • Practices company safety, quality policies, and procedures, actively requires conformance.
  • May require conducting internal and supplier audits.
  • Responding to complaints from customers and investigating the root cause.
  • Migrate and integrate Quality Systems between transfer.
  • Lead validation strategy for transfers.
  • Support internal and external audits, war room others.
  • Comply with all safety policies, practices, and procedures. Report all unsafe activities to supervisor and/or Human Resources.
  • Participate in proactive team efforts to achieve departmental and company goals.
  • Perform other duties as assigned.

Requirements:

  • Bachelor's degree in a related engineering discipline; 2-3 years of related experience.
  • Proficient oral and written English level.
  • Experience in the medical device industry would be an asset.
  • Knowledge of statistics and Minitab is a must.

Other Skills and Abilities:

  • Experienced in managing non-conforming product processes.
  • Proficient in conducting complaint investigations.
  • Skilled in process validation.
  • Knowledgeable in process changes and impact assessments.
  • Competent in risk management.

Comments: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments, and less significant responsibilities.

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