Essential Job Duties: Initial Roles and responsibilities for this position has responsibility will include the following:
50% involvement in supporting design and manufacturing projects, 15% failure investigation, 10% performing complex inspection and 25% quality advocacy and project management.
- Quality Advocacy and Project Management.
- Develop and apply corporate level quality metrics.
- Lead and project manage quality initiatives in one or more of these focus areas:
- Product Quality
- Data Quality
- Process Quality
- Production facility validation planning, execution, and documentation.
- MVP for building, product, and process located in Mexicali, B.C. Mexico.
- Product Development
- Handle projects of various product and subsystem types (System, Instruments, Vision, new products, product improvements, etc).
- Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at, ISI Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge.
- Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
- Develop and implement methods and procedures for disposition of discrepant material.
- Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
- Failure Analysis
- Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
- Perform deep technical failure analysis based on the physics of failure.
Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
Required Skills, Experience, Education, And Training:
Competency Requirements: To adequately perform the responsibilities of this position the individual must possess:
- Requires a minimum of 5 years of related experience with a University degree; or 3 years’ experience and a Master's degree; or a PhD; or equivalent experience.
- Minimum 4+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 2 years in medical device design or manufacturing environment.
- Understands Quality and compliance System.
- Understands of CFR 21 820/ ISO 13485 requirements for making process or design changes.
- Have good grasp of quality control and tools.
- Able to learn the product and process quickly and assesses defects’ impact to product.
- Understands root cause investigation process and able to initiate routine problem-solving investigations.
- Involved in Design and process improvement projects in the past.
- Able to review Qualification and Validation protocols.
- Understands manufacturing metrics.
- Understands basic Excel data analysis operations (e.g., Pareto, charts, and trend).
- Able to work in various project teams as the Quality SME.
- Able to communicate work tasks to various project team members.
- Capable of Compiling data in format appropriate for presentation.
Preferred Skills and Experience
- Able to cope with changes and uncertainties; and handle associate risks comfortably.
- Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
- Brings unpleasant facts to discussion, does not hold back information.
- Driven by results. Fully supports team decision, even if he/she disagrees with the decision.
- Listens and respects others. Demonstrates constructive work relationship with others in the organization.
- Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
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 discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
