Supplier Qual Engineer II at Medtronic in North Haven, Connecticut

Job Description:

Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Join us for a career that changes lives.

Careers That Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a Supplier Quality Engineer II you will have responsibility to provide support for product development programs for new medical device products for the Stapling platform. As an important member of our Quality Team, you will provide guidance and implement strategies that drive component quality, product quality and continuous improvement.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

You will establish and successfully execute supplier management plans which will align to overall business objectives.

• Partners with R&D, NPD Quality, Manufacturing Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
  
  
• Participates in all new product development phase gates including select suppliers, qualify new suppliers, and setup supplier controls.
  
  
• Investigates and reports on supplier corrective actions effectiveness and timeliness
  
  
• Develop and ensure proper execution of the Supplier Quality Strategy.
  
  
• Partner with Supply Chain to integrate strategies and ensure coordination and alignment across Sector.
  
  
• Assist with supplier development by evaluating and developing supplier processes through process and product and/or tooling validations and provide assistance, conduct supplier review meetings and supplier training.
  
  

• Ensures that suppliers deliver quality parts, materials, and services.
  
  
• Qualifies suppliers according to company standards
  
  
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
  
  
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
  
  
• 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 to applicable industry standards, regulatory requirements, and customer requirements.
  
  
• Collaborates with cross-functional 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.
  
  
• Participate in internal and supplier audits
  
  
• Ensure documentation is completed per quality system procedures for supplier process development/validation and product qualification
  
  

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of experience, or advanced degree with 0 years of experience

• Master's degree in Engineering
• Audit experience
• Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
• Strong written and oral communication and presentation skills
• Exposure to statistical analysis
• May have broad knowledge of project management.
• Exposure to FDA regulations/ISO standards for medical devices
• Strong interpersonal, organizational and project management skills
• Demonstrated skills in decision making
• Strong interpersonal communication and influence skill
• Ability to work in a team-based environment
• Computer skills in MS Office and ERP systems desirable

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 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)

Additional Information

• Posting Date: Oct 14, 2021
• Travel: Yes, < 25 % of the Time