Sr Quality Engineer
Sr Quality Engineer
Posted on :
20-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Roles & Responsibilities:
- Initial Roles and responsibilities for this position has responsibility will include the following: 50% involvement in supporting manufacturing operations 25% in product changes or new product introduction projects 15% failure investigation 10% preforming complex inspection and project management.
- Develop and apply corporate level quality metrics.
- Support line transfers between Intuitive buildings and regions.
- Product Development Handle projects of various product and subsystem types (Instruments Accessories 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.
Qualifications :
Skills Experience Education & Training:
- Minimum Education: bachelors degree in electrical mechanical or system engineering math or physics. Advanced degree preferred.
- Proficient in English. Ability to communicate efficiently is a must.
- Minimum 8 years of working experience in Quality Engineering or in manufacturing environment minimum 4 years in medical device design or manufacturing environment.
- Understands Quality and compliance System.
- Understands of CFR 21 Part 820/ ISO 13485 requirements for making process or design changes.
- Has a good grasp of risk assessments (Clinical/Usability risk assessments FMEAs etc.).
- Able to learn the product and process quickly and assesses defects impact to product.
- Understands root cause investigation process and able to initiate routine problemsolving 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
- Personality Requirements: able to cope with changes and uncertainties; and handle associate risks comfortably.
- Ability to bring unpleasant facts to discussion does not hold back information.
- Results driven.
- 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.
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
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
