1+ months

Quality Engineer II

Jacksonville, FL 32216
Quality Engineer II


Jacksonville 6703 Southpoint, Florida, United States

Requisition #:


Post Date:

Aug 27, 2021

**Careers That Change Lives**

In this exciting role as a **Quality Engineer** II you will have responsibility to primarily support process and product quality on assigned production lines (Manufacturing), improve overall process and product quality by incorporating technical solutions using DMAIC/First Time Quality tools, performing detail investigations on quality incidents, addressing non-conformances and improvising technical preventative solutions, conducting process validations and interface with multiple manufacturing functions day to day.

At Medtronic, we believe in the power of medical technology to improve lives. Seven decades ago, our co-founder invented the battery-powered pacemaker. Today, we are among the largest medical device companies in the world. With operations in 150 countries, our products treat 70 health conditions and include cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Our therapies help 72 million people a year and supportour Mission to alleviate pain, restore health, and extend life (https://www.medtronic.com/us-en/about/mission.html) .

Our people make it possible. We value diverse perspectives and encourage our 90,000+ employees to be themselves. We hold each other accountable, act with integrity, and make quality our highest priority.

We are privileged to be part of the communities where we live and work. We are committed to giving back and reducing our impact on the environment.

Lets take healthcare Further, Together.

**A Day in the Life**

In this exciting role as a Quality Engineer II you will have responsibility for ENT Released Product Management and oversight for specified product lines for end to end post-market Quality compliance. Responsibilities may include 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.

+ Experience in Non-Conforming Material Reports with respect to dispositioning and investigating product non-conformances on the manufacturing line.

+ Ability to proactively engage and lead preventative actions on the manufacturing line.

+ Sound knowledge of process validation, process verification, process monitoring, Gage RR activities, with ability to document and execute validation / qualification work.

+ Ability to lead quality deliverables on business critical projects such as Cell Operating System conversions, Kaizen / First Time Quality events.

+ Provides technical guidance and quality compliance for throughout the post-launch product 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.

+ Partner with Supply Chain to integrate strategies and ensure coordination and alignment across Sector.

+ Assist with supplier development by evaluating and developing supplier processes through process and product and/or tooling validations and provide assistance, conduct supplier review and supplier training.

+ Travel requirement:less than 25%

**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 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

**Nice to Have**

+ DMAIC or DRM Green Belt or Black Belt Certifications

+ ASQ CQE/CQA Certification

+ 2 years in Quality Assurance to support development or manufacturing activities

+ Experience in product and process risk management

+ Work experience in the FDA regulated industries (medical device, pharmaceuticals, consumer products, etc.) highly desired; including clean room experience

+ Experience with design and manufacturing transfer to internal sites, both domestic and international

+ Project Management experience and/or certification desired.

+ Ability to troubleshoot product issues in response to customer complaints, based on product design and manufacturing processes

+ Experience in successfully remediating quality systems and product documentation

+ Strong oral and written communication skills with all levels of personnel

+ Experience mentoring junior engineers in developing Quality Engineering skills

+ Cross-functionality and an effective team player.

+ Must be able to handle multiple tasks/projects and manage priorities accordingly.

+ Must be able to work in a team environment and exert influence without alienating others.

**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)
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: 2021-08-31 Expires: 2021-12-06

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Quality Engineer II

Jacksonville, FL 32216

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