Quality Assurance Engineer

hace 3 semanas

Mexicali, Baja California, México Intuitive A tiempo completo

Job Description

Primary Function of Position:

The Quality Assurance department at Intuitive is dedicated to ensuring the safe and effective production of medical devices. As a Quality Engineer, you will play a vital role in identifying and resolving quality issues related to electrical, mechanical, and software subsystems.

Roles & Responsibilities:

  • Develop and validate quality assurance procedures, sampling plans, methods, equipment, and processes.
  • Monitor manufacturing procedures, processes, and records for compliance with established requirements.
  • Evaluate deviations and non-conformances and support resolution of quality issues.
  • Support process validation and verification.
  • Review and trend product and process quality issues using data analysis and root cause investigation.
  • Respond to quality escalations and provide technical support for troubleshooting and testing.
  • Perform risk analysis and determine quality disposition for variance requests and non-conformances.
  • Represent the department cross-functionally in meetings that may include senior and external personnel.
  • Release process and document changes through engineering change orders and deviations using ISI change control process.
  • Escalate to direct management all quality issues that could impact patient safety or surgical efficacy.
  • Ensure successful, on-time completion of department projects, communicate constraints to direct management when successful project completion is at risk.

Qualifications

Skills, Experience, Education, & Training:

  • English Level: High.
  • Demonstrated interest in medical devices, and the medical field.
  • 1-5 years relevant experience in a medical device company (preferred).
  • Requires a minimum of 5 years of related experience with a University degree; or 3 years experience and a Master's degree; or a PhD without experience; or equivalent work experience.
  • Bachelor's degree in Engineering or Life Sciences.
  • Demonstrated understanding of medical device QMS requirements and regulatory requirements, including but not limited to FDA.
  • CFR 21 820 and ISO 13485.
  • Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device environment.
  • Experience with developing and maintaining Standard Operating Procedures and Work Instructions.
  • Ability to learn quickly and understand complex products and processes.
  • Analytical, problem-solving, and root-cause analysis skills.
  • Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when dealing with others.
  • Ability to work independently and handle tasks with competing priorities effectively.
  • Experience with Agile/ACCS and SAP or other electronic documentation systems (Desired).
  • Participation in internal /external audits conducted (preferred).
  • Work experience with highly complicated electromechanical devices (Desired).

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