IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Principal Supplier Quality Engineer

Company: Medtronic GmbH
Location: Irvine
Posted on: September 15, 2020

Job Description:

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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future., "The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it."

"Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on."

This job posting isn't available in all website languages

Set Job Alert

Select

* English (United States)

* English (United Kingdom)

* Français (France)

* Italiano (Italy)

* Deutsch (Germany)

* Portugese (Portugal)

* Español (Spain)

* Nederlands (Netherlands)

* Polska (Poland)

* ??? (Thailand)

* ?? (Japan)

* ???? (South Korea)

* ??????? (China)

* Français (Canada)

* ?????????? ????????? (Russia)

* Medtronic.com

* Applicant Help

* For Our Employees

* Set Job Alert

* Job Search

* Help

Principal Supplier Quality Engineer

Irvine, California, United States

New

Engineering

20000DQR Requisition #

1 day ago Post Date

Careers that Change Lives

In this exciting role as a Principal Supplier Quality Engineer you will support the Neurovascular business manufacture life-saving medical device products. Key responsibilities in this role are managing all internal Medtronic suppliers by working on internal supplier file deliverables and leading the internal supplier oversight and escalation process. You will be responsible for completing internal supplier file deliverables like Quality Agreements between the two internal Medtronic sites. Furthermore, you will perform internal supplier performance monitoring, report the outcome and where applicable, perform more in-depth Quality performance reviews with internal suppliers. You will also support Quality escalation where applicable including managing Internal Supplier Corrective and Preventive Action (iSCAPA). You will work under general direction and will be expected to help further develop the Neurovascular Internal Supplier Quality Process.

The Restorative Therapies Group develops 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.

The Specialty Therapies division of RTG offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose, and throat, as well as stroke products

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

A Day in the Life

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

* Ensures that internal suppliers deliver quality parts, materials, and services.

* Qualifies internal suppliers according to company standards.

* Establish and successfully execute supplier management plans which will align to overall business objectives

* Monitors products, subassemblies and parts from acquisition through the manufacturing cycle and communicates and resolves internal supplier-related problems as they occur.

* Update supplier's records, and supplier performance metrics, produce supplier reports and drive improvements.

* Helps develop and prioritize an RTG internal supplier audit schedule to ensure that designated internal suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

* Evaluates internal supplier's internal functions to assess their overall performance and provides feedback in assessment of their operation.

* Provide Internal Supplier Quality support to new internal suppliers following the completion of a manufacturing transfer project.

* Manage the Internal Supplier Change Control (SCC) process by working with internal suppliers to assess and manage changes.

* Provides technical guidance and quality compliance for Internal Supplier Quality engagement on newly transferred products, subassemblies and parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.

* Collaborates with Component Engineers and Quality Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for products transferred to other sites or new products being received at Neurovascular from other Medtronic sites.

* Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Must Have: Minimum Requirements

Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.

Nice to Have

* Bachelor's degree in Engineering, scientific, or technical discipline.

* 10+ years of engineering experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry.

* 8+ years of directly relevant experience in a Supplier Quality Engineering role (managing either internal or external suppliers).

* 6+ years of medical device experience.

* Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV).

* Prior experience with the Neurovascular medical device industry.

* Advanced degree (MS and/or MBA), Master's degree in Engineering or Scientific field with an emphasis in Engineering, Materials, Quality Assurance, or Quality Systems.

* ISO 13485 Lead Auditor Certification.

* ASQ certified quality engineer (CQE) and/or black belt certification.

* Ability to work with minor guidance and under pressure.

* Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and industry standards where applicable.

* Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes.

* Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies.

* Ability to effectively communicate and work cooperatively with others as a lead member of a team. Must be a team player.

* Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making.

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. Let's 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)

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Sr. R&D Engineer

Irvine, California, United States

Engineering

Requisition #: 200004NG

Design Quality Engineer II - Test Method Validation

Irvine, California, United States

Engineering

Requisition #: 200006WY

R&D Engineer II

Irvine, California, United States

Engineering

Requisition #: 20000DS9

View More Listings

* Job Search

* Help

* Site Map

© Medtronic. All rights reserved.

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You'll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The

Medtronic Mission.

Our mission "to alleviate pain, restore health, and extend life" is more than a statement. It's a belief that our employees live every day.

Learn More

Be part of work that matters. 75 million patients had their health improved by our products last year.

Learn More

WONDERING ABOUT

WORKING AT

MEDTRONIC?

Our employees come from varied backgrounds with a common goal-changing lives.

Learn More

We value what

makes you

unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More

"The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it."

"Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on."

"Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers."

0 0 0

0 0 0

WORKING AT

MEDTRONIC

Be part of one of the world's leading medical technologies and solutions companies.

* Culture and Careers

* Career Development

* Early Career

* Diversity and Inclusion

* Compensation and Benefits

* Applicant Help

* Facebook

* Twitter

* Youtube

* LinkedIn

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

* Medtronic.com

* EEO Policy Statement

* Privacy Statement

* Terms of Use

* Contact

1 0 Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality., * Bachelor's degree in Engineering, scientific, or technical discipline.

* 10+ years of engineering experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry.

* 8+ years of directly relevant experience in a Supplier Quality Engineering role (managing either internal or external suppliers).

* 6+ years of medical device experience.

* Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV).

* Prior experience with the Neurovascular medical device industry.

* Advanced degree (MS and/or MBA), Master's degree in Engineering or Scientific field with an emphasis in Engineering, Materials, Quality Assurance, or Quality Systems.

* ISO 13485 Lead Auditor Certification.

* ASQ certified quality engineer (CQE) and/or black belt certification.

* Ability to work with minor guidance and under pressure.

* Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and industry standards where applicable.

* Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes.

* Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies.

* Ability to effectively communicate and work cooperatively with others as a lead member of a team. Must be a team player.

* Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making., 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)

Keywords: Medtronic GmbH, Irvine , Principal Supplier Quality Engineer, Other , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Speech Language Pathologist - Short-term Coverage(20/21 SY)
Description: We're looking for an--exceptional School Speech Language Pathologist--for a full-time position in Grossmont, CA from October 1st through February 26th. The position will be elementary based 2 school (more...)
Company: TherapyTravelers
Location: La Mesa
Posted on: 09/25/2020

Mgr III Systems Engineering
Description: Raytheon Intelligence and Space RIS is the guiding provider of radar sensor systems. We provide war fighters the most accurate and timely information available for the network-centric battlefield. The (more...)
Company: RTX
Location: La Mirada
Posted on: 09/25/2020

CDL-A Driver Jobs - 1 Yr OTR EXP In Last 5 Yrs OR 6 Mos. OTR EXP In Last Yr Required
Description: Dry Van, Refrigerated, Port Rail Flatbed available Great Pay Monthly Driver Bonus Program with Knight Transportation Interested Call us 844 - Benefits: Great Pay
Company: Knight Transportation
Location: Lake Elsinore
Posted on: 09/25/2020


Stylist
Description: Job DescriptionSupercuts - Stylist You are a stylist with a colorful personality, who works fast, with precision, and attention to detail. And we can't forget about your passion for education. That's (more...)
Company: Supercuts
Location: Cerritos
Posted on: 09/25/2020

Speech Language Pathologist - Short-term (20/21 SY)
Description: We're looking for an--exceptional School Speech Language Pathologist--for a full-time position in La Mesa, CA who can start immediately and work through December 18th. This therapist will work 6.5 hours (more...)
Company: TherapyTravelers
Location: La Mesa
Posted on: 09/25/2020

Caregiver for Group Home
Description: Description Caregiver for Group Home Primary Location: United States-CA-CACarson Function: Direct Support Professional Caregivers Due to the ongoing public health concerns regarding COVID-19, as your (more...)
Company: The MENTOR Network
Location: San Gabriel
Posted on: 09/25/2020

Permanent Hematology-Oncology Physician in San gabriel, California
Description: Hematology-Oncology physician job in California : Pasadena, CA, Area, Hematology/Oncology Job - Must Speak Chinese Clinical Role: Do you know someone that might be a good fit for this position
Company: RecruitWell
Location: Rosemead
Posted on: 09/25/2020

IRB Scientific Regulatory Board Chairperson
Description: General Information Location: Cary, NC, Needham, MA, Santee, CA Organization: Western Institutional Review Board Description And Requirements We're looking for dynamic and motivated professional to join (more...)
Company: WIRB-Copernicus Group
Location: Santee
Posted on: 09/25/2020

DBA
Description: DBA JD br UST Global is looking for a DBA to work with one of the leading healthcare providers in US. The ideal candidate must possess excellent technical knowledge. The candidate must possess excellent (more...)
Company: UST Global Inc
Location: Cerritos
Posted on: 09/25/2020

Postmates - Earn Extra Cash
Description: Postmates has the largest on-demand fleet in the U.S. with 200,000 Postmates, and an equally extensive network of merchants. While some companies try to build a warehouse outside of a city and funnel (more...)
Company: Postmates
Location: Diamond Bar
Posted on: 09/25/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds