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