Posted in Other 30+ days ago.
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Type: Full Time
Location: Batesville, Indiana
Hill-Rom is a $2.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions.
DescriptionThe Supplier Quality Engineer will provide direct Supplier Quality Support to our Batesville, IN Manufacturing Operations. This individual is responsible for leading quality initiatives with suppliers to improve purchased part/service quality, drive quality system improvements, and ensure compliance to regulatory and procedural requirements. The Supplier Quality Engineer must have knowledge of the company's manufacturing process, applications, and process development. Quality audits must be performed on suppliers to assure products and services meet ISO13485 / ISO9001 and relevant regulatory standards.
* Responsible for the quality of electronics/electro-mechanical suppliers for Batesville Operations.
* Interface with supplier's engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.
* Support operations in trouble-shooting electronics non-conformities to confirm purchased parts defects.
* Maintain and monitor approved supplier list (ASL) in compliance with procedures (including leasing supplier audits).
* Lead supplier new part qualification activities, including development of capability studies and control plans that define the supplier's processes and identify areas of risk. Review and approve engineering design changes and supplier change requests to determine part re-qualification needs.
* Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.
* Measure and communicate supplier performance on key quality metrics and develop continuous improvement plans.
* Develop and drive departmental continuous improvement projects to improve procedure and processes efficiency to better support the business.
QualificationsBachelor of Science in Engineering required, Mechanical/Industrial/Manufacturing related fields preferred * 2+ years of manufacturing, quality assurance, and/or engineering experience preferred
* Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required.
* Working knowledge of standard quality system requirements (ISO 9001, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation) preferred.
* Supplier quality experience in medical device or related GMP environment preferred
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