Quality Engineer
Quality Engineer
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Job Description
Primary Function of Position:
The Quality Assurance department is devoted to assuring safe reliable and effective products that exceed patient surgeon and hospital expectations. The department plays a vital role in product and process quality supporting commercial production for all da Vinci Surgical System product lines including system platforms endoscopic instrumentation and supporting accessories. The Quality Engineer 3 (QE) works with a team of dedicated individuals supporting manufacturing operations to assure quality of finished product and identify quality issues related to electrical mechanical and software subsystems. The QE evaluates product quality issues performs root cause analysis identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure.
Roles & Responsibilities:
Develops and validates quality assurance procedures sampling plans methods
equipment and processes.
Monitors manufacturing procedures processes and records for compliance with
established requirements.
Evaluates deviations and nonconformances and supports resolution of quality
issues.
Supports process validation and verification.
Reviews and trends product and process quality issues using data analysis and
root cause investigation.
Responds to quality escalations and provides technical support for
troubleshooting and testing.
Perform risk analysis and determines quality disposition for variance requests and
nonconformances.
Represents the department crossfunctionally in meetings that may include senior
and external personnel.
Releases process and document changes through engineering change orders
and deviations using ISI change control process.
Escalates to direct management all quality issues that could impact patient safety
or surgical efficacy.
Ensures successful ontime completion of department projects communicates
constraints to direct management when successful project completion is at risk.
Performs other duties as assigned by management.
Qualifications :
Skills Experience Education & Training:
English Level: High.
Demonstrated interest in medical devices and the medical field.
Bachelors 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 problemsolving and rootcause 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.
15 years relevant experience in a medical device company (preferred).
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).
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
