Quality Engineer 3

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 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.

Qualifications

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).