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Principal Supplier Quality Engineer


Sunnyvale, CA 94086
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Job Details

Principal Supplier Quality Engineer


Sunnyvale, California, United States

Requisition #:


Post Date:

Jan 06, 2021

**Principal Supplier Quality Engineer**

**Req Number: 20000IN4**

**Sunnyvale, CA**

**Careers That Change Lives**

We are looking for a dynamic and adaptive Principal Supplier Quality Engineer, with the desire to be part of the fast-growing Cardiac Ablations Solutions business, helping us to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

In this exciting role as a Principal Supplier Quality Engineer, you will have responsibility for the quality of components used for catheter production at the Sunnyvale Stewart Operations Manufacturing Site. The Principal SQE supports all component suppliers and contract manufacturer product to ensure highest product quality and assure compliance to internal procedures and applicable external standards and 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 ABLATION SOLUTIONS** provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes.

**A Day in the Life**

+ Provides guidance and leadership for quality and compliance including NCMR, CAPA, root cause analysis, production support, audits, issue trending and good documentation practices

+ Ensure components are inspected and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications

+ Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

+ 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.

+ 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 andassociated test method validation for all internal Medtronic Test Methods.

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

**Nice to Have (Preferred Qualifications)**

Medical device operations experience

Supplier Quality engineering experience

Cross-functional knowledge and/or experience.

Ability to build a strong cohesive cross-functional team through motivational and teambuilding skills.

Good communication (oral and written), presentation and interpersonal skills.

Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals.

Demonstrates initiative; results oriented.

Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of several functional departments. Makes timely decisions in the face of risk and uncertainty.

Lean six sigma methodology / DFSS / DRM recommended

**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)

Up to 25% Travel
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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