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USA - Sr. Quality Engineer

3 months ago

Cleveland, United States eTeam Full time

Job Title: Supplier Quality EngineerLocation: Cleveland, MS- 100% OnsiteDuration: 6+ MonthsPay Rate: $55.00/hr on W2 to $58.00/hr on W2Job Description:•Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.•Works with suppliers to find solutions to identified problems.•Create written reports and communicate the results clearly and effectively to the auditee and Client's management.•Manage and insure timely implementation of supplier Corrective Action Reports (SCARs).•Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues.•Remediate Supplier files to support current and business development activity related to acquisition of new businesses.•Remediate SNC Process,•Verify supplier files are maintained and documented appropriately.•Provide supplier metrics to management.•Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.•Develop Improvement plans for Critical to quality suppliers.•Manages personnel to maintain and reduce the Incoming Inspection cycle time.•Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory•.Perform component characteristic analysis to determine inspection status changes.What you'll bring•Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification.•B.S Degree in Engineering required.•5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills desirable.•Oral and written communications in English