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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.
- 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
USA - Sr. Quality Engineer - Cleveland, United States - eTeam
Description
Job Title:
Supplier Quality EngineerLocation: Cleveland, MS- 100% OnsiteDuration: 6+ Months
Pay Rate:
$55.00/hr on W2 to $58.
00/hr on W2Job Description: