
Website Medtronic
Job Description:
In this exciting role as a Supplier Quality Engineer II you will have responsibility for In this exciting role as a Supplier Quality Engineer II 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.
Job Responsibilities:
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Travel requirement: less than 25%
- 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.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- Ensures that suppliers deliver quality parts, materials, and services.
- Some individuals may have responsibilities that include Post-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to sustaining, RPM and Transfer projects working in partnership with the Engineering, Ops Quality, and R&D 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 Product lifecycle on newly/legacy qualified parts 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 Site Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
Job Requirements:
- Excellent presentation skills.
- Cross-functionally and an effective team player.
- Working knowledge of appropriate industry standards.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Knowledge/basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
- Knowledge with PPAP process and part/product validation and qualification.
- Certified Quality Engineer, Reliability Engineer, or equivalent desired.
- Strong oral and written communication skills.
- Must be able to work in a team environment and exert influence without alienating others.
Qualification & Experience:
- Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced
- Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.
- Bachelors or Masters Degree in Electrical Engineering, or other related engineering degree strongly preferred.
- Experience in medical device design and application of test standards.
- Experience in application statistical methods to design reliability and process capability.
- Experience in application statistical methods to design reliability and process capability.
Job Details:
Company: Medtronic
Vacancy Type: Full Time
Job Location: Jacksonville, FL, US
Application Deadline: N/A
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