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Engineering
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18000HMR Requisition #
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Careers that Change Lives 
Your dedication is important to our customers and, most importantly, to their patients.
 
Medtronic is currently seeking a Supplier Quality Engineer.

This position has the responsibility to perform Quality Engineering functions including inspection and testing, procedure writing, statistical analysis of quality data, supplier qualification and performance monitoring and reviewing and approving design changes,
 
Do meaningful work, make a difference, and improve lives — starting with your own. 

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
 
 


A Day in the Life
•Enforces adherence to the Quality Management System through procedural compliance and support of internal and external audits
•Actively participate in the product development cycle to ensure quality issues are addressed and resolved prior to release.  Complete reviews and audits of Design History File documentation.
•Review and approve appropriate qualifications, validations, inspection plans and gauging for both new products and changes to released product.  Assure the resolution of all issues raised by testing.
•Review, approve, and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Establish incoming inspection requirements and revise as necessary.
•Participates in problem solving efforts to identify and resolve difficult quality issues to ensure production of safe and effective medical devices. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.  
•Perform machine and process capability and performance studies. Lead the implementation of changes and upgrades to systems, procedures, and processes to improve product quality. Provide well-written reports and supporting documentation.
•Assist in the development and assessment of the supplier program. Address problems and recommend solutions to supplier quality. Disposition nonconforming product at the Material Review Board meetings. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments.  Support supplier corrective and preventive actions.
•Implement corrective and preventive actions to improve quality.  Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.
•Ensure process qualification and process validations are appropriate and accurate.
•Support equipment and process validation by participating in the development of studies and validation protocols to assess manufacturing capability/reliability.
•Assures sound statistical and scientific design for all studies, sampling, and testing, process trending and SPC data.
•Supports the sustainment of existing products through NCMR investigations, Implementation Change Order management and Supplier Change Request approvals.


Responsibilities may 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.
Must Have: Minimum Requirements 

EDUCATION REQUIRED:  
•Bachelor’s Degree in Engineering

YEARS OF EXPERIENCE  
•0+ years of experience with Master’s Degree
•2+ years of experience with Bachelor’s Degree



Nice to Have 

•3+ years of Engineering experience in a regulated environment; preferably Orthopedetic implants.
•Knowledge and experience in an Orthepedics implants related business
•Working knowledge of ISO quality system (ISO13485), USFDA Quality System Regulation, and relevant international standards.
•Self-Starter and accountable, with sharp focus on quality and customer experience.
•Working knowledge of problem solving and statistical methods as applied to process and product quality.
•Experience working with remote suppliers and facilities, both domestic and international.
•ASQ certification or equivalent
•Ability to interact with senior external personnel on significant technical matters often requiring coordination between organizations.
•Ability to guide the successful completion of major programs and an ability to perform in a leadership role. 
•Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.  
•Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures
•Strong oral and written communication skills.
•Ability to follow specific, detailed instructions.
•Proficiency using SAP.
•Must be able to work cross-functionally across other departments.
•Must be able to handle multiple tasks/projects and manage priorities accordingly.
•Must have a high tolerance for ambiguity.
•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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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