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
Senior level auditor for the Enterprise Global Supplier Quality Audit program
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.


• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.


• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD 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 with applicable industry standards, regulatory requirements, and customer requirements.


• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.


• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Minimum Requirements

• Bachelor's degree required


• Minimum of 4 years of relevant experience, or advanced degree with 2 years of experience

• Broad Technical & QMS Knowledge


• Lean Manufacturing/ Greenbelt training


• Experience working with Suppliers, audit observations


• Lead Auditor experience/knowledge


• Problem solving ability


• Statistical training


• Prior medical device industry experience or other regulated industry such as pharma, aerospace, auto, etc.


• Medical device manufacturing industry experience, preferably ISO 13485.


• Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.


• ASQ CQE, CQA and/or CSQP certification preferred


• 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

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 .

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.