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Quality Engineer - Cleveland, United States - Stefanini
Description
Stefanini Group is hiring Stefanini is looking for Supplier Quality Engineer in Cleveland, MSFor quick Apply, please reach out to Bhavishya Yagnik - call:
/ email:
Work Hours:
M-F (40 hours)
Work Location:
Cleveland, MS
Shift:
1st Shift
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.
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