17 days old

Principal Supplier Quality Engineer

Medtronic
Mounds View, MN 55112
Principal Supplier Quality Engineer

Location:

Miami Lakes, Florida, United States

Requisition #:

19000BB3

Post Date:

Aug 02, 2019


**Careers that Change Lives**


As a Principal Supplier Quality Engineer, you will be responsible for the management of suppliers/OEMs within the BU, with accountability to support selection, approval and qualification of new suppliers/OEMs or changes to existing supplied products and processes, as well as oversight of performance and improvement activities.


You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.


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.


CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.


**A Day in the Life**


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


+ Ensures that suppliers deliver quality parts, materials, and services.

+ Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

+ Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

+ Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

+ Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

+ Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

+ Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD 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 to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

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


**Must Have: Minimum Requirements**


Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Masters Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.


**Nice to Have**


7+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.

ASQ CQE certification

ASQ Lead auditor certification

Manufacturing processes or RD experience

Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls

PC skills, MS Office (Word, Excel, PowerPoint and Project)

Advanced use and understanding of statistical tools

Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485


**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 can be up to 25% globally.
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.

Categories

Posted: 2019-08-06 Expires: 2019-09-12

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Principal Supplier Quality Engineer

Medtronic
Mounds View, MN 55112

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