Sr Supplier Quality Engineer
Careers That Change Lives
In this exciting role as a Senior Supplier Quality Engineer you will have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams.
The Restorative Therapies Group develops life-restoring technologies and solutions to treat diseases in the areas of neurosciences, ENT and pelvic health. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.
BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Partners with R&D, Business Development, 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.
- Participate on Corporate Supplier Quality Teams.
- 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.
- Develops 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.
- Leads Supplier Qualification activities: Supplier Audits & Supplier Quality Agreements.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
Nice to Have: Preferred Requirements
- Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management
- Experience in application statistical methods to design reliability and process capability
- Degree in Engineering or Quality discipline
- ASQ certification in Quality Engineering
- Experience and working knowledge of FDA regulations/ISO standards for medical devices
- Strong interpersonal, organizational and project management skills
- Demonstrated skills in decision making
- Demonstrated ability in coaching/developing team members
- Demonstrated communication skills, both verbal and written
- Strong interpersonal communication and influencing skills
- Ability to work in a team-based environment
- Very strong in quality and compliance
- Computer skills in MS Office and ERP systems desirable
Travel:
In this role – periodic travel is expected. Travel is less than 25%.
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 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)
