At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
A career at Medtronic is like no other. We're committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!
In this exciting role as a Sr. Supplier Quality Engineer you will have responsibility for management of suppliers within the Dexter, MI SQE team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities.
You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Responsibilities may include the following and other duties may be assigned.
Improve suppliers' performance and reduce escapes to manufacturing.
Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
Lead suppliers' change requests, including communication, project management, and regular reporting.
Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.
Ensure suppliers deliver quality parts, materials, and services.
Qualify suppliers according to company standards.
Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
Plan and execute supplier qualification QMS audits per quality standards.
Evaluate suppliers' internal functions to assess overall performance and provide feedback.
Collaborates to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
Manage the Approved Supplier List, including administrative work.
The job may require travel to suppliers within the United States and internationally.
Must Have: Minimum Requirements
Bachelor's degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Nice to Have
Experience with manufacturing and polymers (extrusion, injection molding).
Experience with executing PPAP (Production Part Approval Process) for plastic injection molding and/or electronic commodities.
Medical device manufacturing industry experience, preferably ISO 13485.
Lead auditor experience.
Ability to manage tasks and projects under tight deadlines with a sense of urgency.
Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
ASQ CQE, CQA and/or CSQP certification
First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
Possess a minimum of 2 years' experience with each of the following:
Supplier Change Process evaluation and implementation
CAPA, Supplier related Product and Process NCMR
Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews.
Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T
IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method Validations, and Measurement System Analysis.
Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls
GMP for Class II and Class III medical devices.
FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 & ISO 14971.
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 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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$94,400.00 - $141,600.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .
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.
At Medtronic, most positions are posted on our career site for 3-7 days.
Welcome to our new Careers Site!
If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
