Supplier Quality Engineer (m/f)

REFERENZNUMMER:

325073/10

IHRE AUFGABEN:

-Interface with supplier‘s engineering and quality organizations
-Drive corrective and preventive actions at the supplier to preclude recurrence of identified issues
-Perform direct and indirect supplier evaluations
-Implement supplier risk analysis and mitigation plans
-Maintain and monitor Approved Supplier List
-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 requalification needs
-Develop supplier’s knowledge and implementation of quality tools and techniques

IHRE QUALIFIKATIONEN:

-Bachelor of Science in Engineering
-Electrical/Electronic engineering knowledge preferred
-Profound quality assurance and/or engineering experience preferred
-Experience with US medical device regulations (21 CFR Parts 820, 803, and 806)
-Experience with standard quality system requirements (ISO 9001, EN ISO 13485, Medical Device Directive, Canadian Medical Device Regulation)
-Supplier quality experience in medical device

WEITERE QUALIFIKATIONEN:

Quality manager