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1+ months

Principal Quality Engineer

Tempe, AZ 85282
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Principal Quality Engineer


Tempe, Arizona, United States

Requisition #:


Post Date:

Oct 07, 2020

**Careers That Change Lives**

In this exciting role as a Principal Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of Diabetes related products at Medtronics Tempe Campus.


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.

+ Ensure internal quality processes, procedures and systems are compliant to all governing standards.

+ Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.

+ Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.

+ Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.

+ Support risk assessment processes for manufacturing and development including process FMEA and design FMEA,ensuring risk assessments are thorough and documentation meets all governing requirements.

+ Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.

+ Support CAPA investigations, improvements and effectiveness verification testing

+ Lead and/or support investigations of non-conforming product, materials or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. The Principal Manufacturing Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.

+ Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures and systems to meet organizational objectives.

+ Facilitate group meetings and project leadership that drives comprehensive technical solutionsformultiple issues and projects simultaneously

+ Communicate clearly regarding technical issues and solutions

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

+ 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.

+ May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

**Must Have: Minimum Requirements**

Bachelors degree in Engineering, Science or technical field with 7+ years of experience in Quality and/or Engineering, or advanced degree with 5+ yearsof experience in Quality and/or Engineering

**Nice to Have**

+ Experience withelectronics manufacturing including wafer fabs and electronics assembly.

+ Strongbackground inEquipment Development, IQ, ProcessCharacterization, OQPQ, and Test Method Development and Validation.

+ Six Sigma orLean Sigma belt certification

+ DRM or DFSScertification

+ Experience withinternal and external audits including FDA, MDSAP and/or TUV.

+ 5+ years of engineering experience in amedical device manufacturing environment

+ 5+ years of Process Quality or ProcessEngineering experience.

+ Strong understanding of medical devicemanufacturing processes and products

+ Experience with general quality principles,procedures and methodologies

+ Strong understanding of regulatoryrequirements (i.e.: ISO, FDA-GMP, etc.)

+ Strong statistical analysis techniques

+ Strong technical writing skills

+ Good overall communication and presentationskills, as well as experience with presentation tools and applications

+ Able to make technical dispositions ofmaterials using a microscope

**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)

Some travel may be required not to exceed 10% of the time.
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.


Posted: 2020-09-17 Expires: 2021-01-25
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Principal Quality Engineer

Tempe, AZ 85282

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