Medtronic Supplier Quality Engineer II in United States
Supplier Quality Engineer II
3 days ago
Supplier Quality Engineer II
Careers That Change Lives
In this exciting role as a Supplier Quality Engineer II Post-Market Quality you will have the responsibility to provide technical guidance and quality compliance for Supplier Quality engagement throughout the product lifecycle on commercially available products. You will work in partnership with multiple functions including but not limited to the Technical Sourcing, Manufacturing and Pre-Market Supplier Quality Teams to deliver quality parts, materials, services and prevent defects. You will work with suppliers to allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485) and company Quality System procedures.
Perform statistical analysis using Minitab to ensure supplier has acceptable capability in process validations.
Perform GRR, TMVs and review / approve IQ/OQ/PQ data from supplier qualifications.
Quality governance of selection of new suppliers to the Approved Supplier List (ASL)
Develops and prioritizes an auditing schedule to ensure that new suppliers are audited initially as part of their qualification process.
Prepare and negotiate Quality Agreements with suppliers
Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Collaborates with Manufacturing Engineers to sustain Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for commercial products.
Sustain Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
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 experience in Quality and/or Engineering OR Advanced degree inEngineering, Science or Technical field with 0+ years of experience in Quality and/or Engineering
Nice to Have
Demonstrated communication skills, both verbal and written, Strong interpersonal communication and influence skill
Prior experience in regulated medical devices is desirable.
DMAIC certification/ Knowledge and experience in areas of Lean Manufacturing and Six Sigma
ASQ certification in Quality Engineering
Design for Reliability and Manufacturing knowledge
Able to perform statistical analysis in Minitab
Supplier Qualification process knowledge and experience
Strong interpersonal, organizational and project management skills
Able to use critical thinking skills.
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 25% Domesticand International as applicable.
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.