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Quality Supplier Engineer

Company: Medtronic
Location: santa ana
Posted on: May 3, 2021

Job Description:

Careers that Change Lives

In this exciting role as a Senior Supplier Quality Engineer youwill have responsibility for ensuring the overall strategy, planning, andexecution of all supplier quality activities for a Transcatheter Mitral ValveReplacement product. This job isprimarily focused on pre-market activities in support of commercialization of anew and exciting technology within the Structural Heart business. This role will report directly into theDirector of Quality for TMVR and have good visibility within the organization.


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

CORONARY AND STRUCTURAL HEART provides interventionaldevices to treat coronary arteries that are blocked by atherosclerotic plaqueand devices and therapies to treat structural defects of the heart.

A Day in the Life

Responsibilitiesmay 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: MinimumRequirements

Tobe considered for this role, please ensure the minimum requirements are evidenton your resume.

Bachelors Degree inEngineering, Science or technical field with 4+ years of work experience inEngineering and/or Quality OR Advanced degree in Engineering, Science ortechnical field with 2+ years of work experience in Engineering and/or Quality

Nice to Have

Proficient in statistical analysis and techniques for acceptance plans

ISO 13405 and 21 CFR 820 knowledge and experience working within medical devicequality management systems

Auditing experience and or relevant certifications Test method experience

Medical Device materials processing, component feature analysis,and component qualification experience

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limitsof what technology, therapies and services can do to help alleviate pain,restore health and extend life. We challenge ourselves and each other tomake tomorrow better than yesterday. It is what makes this an exciting andrewarding 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 worktogether 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 jobdescription are representative of those that must be met by an employee tosuccessfully perform the essential functions of this job. Reasonableaccommodations may be made to enable individuals with disabilities to performthe essential functions. For Office Roles: While performing the duties of thisjob, the employee is regularly required to be independently mobile. Theemployee is also required to interact with a computer, and communicate withpeers and co-workers. Contact your manager or local HR to understand the WorkConditions and Physical requirements that may be specific to each role.(ADA-United States of America)

Some travel will be required to vendors at approximately 25%of the role

Additional Information
  • Posting Date: Nov 2, 2020
  • Travel: Yes,

Keywords: Medtronic, Santa Ana , Quality Supplier Engineer, Other , santa ana, California

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