at Medtronic in Memphis, Tennessee, United States
Sr Quality Engineer
Memphis, Tennessee, United States
Aug 26, 2021
Sr. Quality Engineer
Careers That Change Lives
In this exciting role as a Sr. Quality Engineer you will have responsibility for assuring Medtronics requirements are met in a fast-paced distribution environment. This role is located at the Memphis, TN distribution center and supports the storage and handling of Medtronics extensive product portfolio throughout the global distribution network.
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life of a Sr. Quality Engineer will be but not limited to the following:
+ Assures compliance with relevant regulatory requirements and associated standards (e.g. 21 CFR 820 ISO 13485) and policies
+ Develops and maintains quality processes including the following:
+ Risk Management pFMEAs and other process risk documentation
+ Change Control provide engineering support for process changes
+ Equipment and process validation – including So-Low Freezers and autoclaves
+ Product repackaging new and sustaining product
+ Process control environmental monitoring process and equipment
+ Calibration and test equipment gauges
+ Collaborates across multiple functions, operating units, and geographies to assure requirements are met
+ Performs first article inspections on repackaged product
+ Drives continuous improvement opportunities
+ Supports quality culture improvement initiatives
+ Participates on enterprise-wide project teams and committees, as assigned
+ Other duties, as assigned
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.
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 4+years of experience in Engineering and/or Quality or Advanced degree in Engineering, Science or Technical field with 2+ years of experience in Engineering and/or Quality.
Nice to Have (Preferred Qualitifications):
+ Bachelors or Masters degree in mechanical, electrical or biomedical engineering or related field
+ Knowledge of medical device regulations, standards, guidelines, directives, global and domestic standards as applicable.
+ Operations or Quality experience in a distribution environment
+ Skillful in formulating strategies, tactics and action plans to achieve results
+ Strong focus on developing an organizational culture that fosters teamwork
+ Ability to effectively influence key decision makers
+ Ability to work well under pressure and maintain positive, enthusiastic attitude
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)
Travel up to 30%
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.