Quality Engineer 3

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 non-conformances 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
non-conformances.
•Represents the department cross-functionally 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, on-time completion of department projects, communicates
constraints to direct management when successful project completion is at risk.
•Performs other duties as assigned by management.
Skills, Experience, Education, & Training:
• 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 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.
• 1-5 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).

Employment type
Full-time

Work arrangement
No