Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Quality Assurance Engineer II for Cerenovus located in Fremont, CA.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
You, the Quality Assurance Engineer II in Quality Operations will:
Support implementation of specifications for incoming, in-process, and final quality inspections and tests, including statistically based sampling plans, forms, instructions for recording, evaluating, and reporting data,
including SPC, as appropriate.
- Support and records any product quality issues. Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
- Initiate action to prevent the occurrence of product nonconformity and verify implementation.
- Supports Quality Assurance in teams for new product development and ensure the development process follows established SOPs, including verification, validation, and aging studies.
- Pay close attention to detail to ensure that all appropriate documentation is complete and current for the assigned product lines and that changes to documentation are reviewed, approved, and validated as appropriate, prior to implementation.
- Develops and analyze statistical data and product specifications to determine present standards and
establish proposed quality and reliability expectancy of finished product.
- Monitor, measure and communicate key quality performance metrics, identifying favorable and negative trends. Recommend modifications of existing products, materials, or components to achieve the established quality standards and overall reliability standards.
- Perform verification/validation processes and the development of protocols, evaluation of data and reports in conjunction with appropriate functions.
- Support the establishment of processes to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
- Investigates, recommend and/or verify implementation of appropriate Corrective and Preventive Actions (CAPA) for quality issues, in coordination with management, engineering, operations, and others.
- Prepare and revise procedures, and work instructions.
- Escalates to management for interface on quality activities with internal or external organizations (customers, suppliers, subcontractors, and others) and propose solutions
- Guides project teams to develop DOEs and statistically sound tests for appropriate support of results. Gathers and analyzes information skillfully; Develops alternative solutions; Uses basic business principles to guide decisions
- Support FDA inspections, ISO Certification and surveillance audits, preparation and follow-up activities.
- Possess ability to work collaboratively with a team or independently, with an eye for detail and a methodical approach to problem solving.
- Provide technical guidance to QA personnel as needed.
- Employees in this class perform complex professional engineering work, exercising independent judgment in planning work details for themselves and their subordinates.
A Bachelor’s degree is required.
A minimum of 2 years relevant working experience.
A BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science is preferred.
Medical Device experience is preferred.
Familiarity with six sigma training and statistical tools is preferred.
An ASQ Certification is preferred.
Experience collaborating with external suppliers is preferred.
Working knowledge of product reliability, reliability engineering and stability is preferred.
Risk Management experience is preferred
Process Capability experience and Process Validation experience is preferred
A working knowledge and application of industry regulations. QSR, MDD, ISO 13485, ISO 14971,cGMP, and other international standards is preferred.
Data analysis (statistical analysis, sampling plans, Statistical Process Control, etc) experience is preferred.
Prior experience with root cause investigations is preferred.
Prior CAPA and/or Non conformance experience is preferred.
Prior experience with statistical software is preferred.
Proficiency in Minitab is preferred.
This position will be located in Fremont, CA and may require up to 10% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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