Quality Assurance Specialist
hace 2 semanas
Company Overview
At Intuitive, we're driven by a shared passion to improve patient lives through minimally invasive care. Our team of innovators and experts is dedicated to helping surgeons and hospitals overcome the challenges of healthcare.
We're a leader in the field of robotic surgery, and our commitment to diversity and inclusion has earned us a reputation as a top employer. Our company is built on the principles of respect, integrity, and a passion for learning.
Job Summary
The Quality Assurance department plays a critical role in ensuring the safety and effectiveness of our products. As a Quality Engineer, you'll work with a talented team to identify and address quality issues, develop and implement quality assurance procedures, and support process validation and verification.
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.
Requirements
English Level: High.
Demonstrated interest in medical devices, and the medical field.
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.
Ability to work independently and handle tasks with competing priorities effectively.
1-5 years relevant experience in a medical device company (preferred).
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