1+ months

Principal Quality Engineer (Process QA)

Tempe, AZ 85282
Principal Quality Engineer (Process QA)


Tempe, Arizona, United States

Requisition #:


Post Date:

Aug 01, 2019

**Careers That ChangeLives**

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.

**A Day in the Life**

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

+ Develops, modifies, applies and maintains qualitystandards and protocol for processing materials into partially finished orfinished materials product.

+ Collaborates with engineering and manufacturingfunctions to ensure quality standards are in place.

+ Devises and implements methods and procedures forinspecting, testing and evaluating the precision and accuracy of productsand production equipment.

+ Designs or specifies inspection and testing mechanismsand equipment; conducts quality assurance tests; and performs statisticalanalysis to assess the cost of and determine the responsibility forproducts or materials that do not meet required standards and specifications.

+ Ensures that corrective measures meet acceptablereliability standards and that documentation is compliant withrequirements.

+ May specialize in the areas of design, incomingmaterial, production control, product evaluation and reliability, inventorycontrol and/or research and development as they apply to product orprocess quality.

**Must Have: Minimum Requirements**

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

**Nice to Have (Preferred Qualifications)**

+ 4+ years of engineering experience in a medical device manufacturing environment

+ 3+ years of Process Quality or Process Engineering experience.

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

+ Strong background inEquipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.

+ Strong statistical analysis techniques

+ Strong technical writing skills

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

+ Chemical Engineering or Chemistry experience

+ Six Sigma or Lean Sigma belt certification

+ DRM or DFSS certification

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

**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 trael may be required not to exceed 10% of 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: 2019-08-06 Expires: 2019-10-17

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Principal Quality Engineer (Process QA)

Tempe, AZ 85282

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