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1+ months

Sr Quality Engineer

Medtronic
Irvine, CA 92604
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Sr Quality Engineer

Location:

Irvine, California, United States

Requisition #:

2000091I

Post Date:

Jan 22, 2021


**Careers That Change Lives**


The Medtronic **Restorative Therapies Group** in Irvine, CAdevelops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.


We are currently looking for dedicated and motivated **Sr Quality Engineer** to join our brain therapiesteam. This teamoffers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.


Medtronic is intensely focused on creating a workplace environment which reflects our standing as the worlds top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business.


Do meaningful work, make a difference, and improve lives starting with your own.


Come for a job, stay for a career.


**A Day in the Life**


As a **SrQuality Engineer** you will be responsible for the successful implementation of projects andactivities to define, design, develop and deliver new processes, quality improvement and change initiatives.


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


+ Provides Quality Engineering support for commercial neurovascular products.

+ Applies knowledge of design control principles, statistics, process systems validation, and quality engineering techniques to positively influence projects and manufacturing.

+ Executes Test Method Validation and Process Validation.

+ Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.

+ Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.

+ Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

+ Navigates complex government regulations to include FDA QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.

+ Present technical data to groups within and outside the organization.

+ 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.


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience


**Nice to Have (Preferred Qualifications):**


+ Masters degree preferred

+ ASQ-CQE, CQA, CBA or equivalent certifications

+ Medical device experience; or experience in a regulated environment

+ Experience working with suppliers and/or contract manufacturers

+ Strong analytical skills

+ Excellent communication skills

+ Ability to work effectively within team and across functions


**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)
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: 2021-01-26 Expires: 2021-05-03
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Sr Quality Engineer

Medtronic
Irvine, CA 92604

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