Intuitive's da Vinci® Surgical System adoption is increasing, requiring a focused team to enhance reliability, quality, and safety for products in use, manufacturing, and design.
Requirements
- Demonstrated proficiencies of 21 CFR 820, ISO 13485 and ISO 14971 requirements for making process or design changes.
- Understands product risk management, experience in generating/updating FMEAs (dFMEA, pFMEA and uFMEA).
- Understands Design Controls, Change Controls, Product, and Engineering Processes.
- Proficient with generation and execution of Qualifications, Validation protocols and Quality Assurance Procedures.
- Experienced in leading product containment and rework activities.
- Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
- Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.
Responsibilities
- Support sustaining manufacturing operations, including failure analysis.
- Engage in design controls.
- Advocate for quality and drive continuous improvements.
- Support manufacturing processes by reviewing and approving quality documentation, qualifying equipment, and managing defect containment.
- Assist in the development and execution of process validation and verification test plans, protocols, and reports.
- Provide quality expertise to the failure analysis team to analyze the returned product (RMA).
- Represent service Quality in the design control process including planning and execution of design verification and validation and risk management.
Other
- Minimum of 7+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 5 years in medical devices or manufacturing environment.
- 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.
- Escalates issues/potential issues to direct management that could impact compliance, 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.
