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Quality Engineer II

Medtronic
Irvine, CA 92604
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Quality Engineer II

Location:

San Juan Capistrano, California, United States

Requisition #:

210000EM

Post Date:

Jan 09, 2021


**Quality Engineer**

**210000EM**

**San Juan Capistrano, CA**


**Careers That Change Lives**


In this exciting role as a Quality Engineer you will have responsibility for day to day quality engineering support ensuring Medtronic products maintain their high level of quality by establishing and monitoring inspections and process controls, evaluating and documenting the risks associated with processes, assessing and determining effects of non-conformances and making product decisions based on the assessments, participating in the implementation of new product processes, and determining and implementing process improvements that improve product quality and/or reduce costs while maintaining product quality.


**CVG**


The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe


**AORTIC, PERIPHERAL AND VENOUS (APV)** offers treatment for vascular abdominal and thoracic aortic disease, interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies and venous therapeutic solutions for superficial and deep vein diseases.


**A Day in the Life**


**Responsibilities may include the following and other duties may be assigned.**


+ Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

+ Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

+ Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

+ Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

+ May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.


**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**


Bachelors Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality


**Nice to Have**


Experience supporting product/ medical device software


DMAIC or DRM Green Belt or Black Belt Certifications


Direct experience with 21CFR Part 820 and ISO 13485 and Quality system requirements in other geographies.


Experience in a Clean Room environment


Experience in product and process risk management


**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)


Travel up to 25%
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2021-01-12 Expires: 2021-02-19
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Quality Engineer II

Medtronic
Irvine, CA 92604

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