Job Description
Job Description
Title: Supplier Quality Engineer
Location: Cleveland, MS. ONSITE.
Duration: 6 months with the possibility of
extension/conversion
"RELOCATION CANDIDATE CONSIDERED"
Need help with remediation efforts and to backfill one other team member.
Transitioning from paper-based process to electronic system (Track wise).
Makes sure all assessments are completed - There are 180 records in process.
Track wise is ideal, Any other similar Electronic based supplier process system would work.
3-5 years in supplier process
Experience in change control, Assessments.
Onsite 5 days a week. Willing to look at relocation candidates.
Pharma industry is highly preferred but willing to look at candidates from any manufacturing industry
Possibility for extension but conversion is not possible at this time
Bachelor's degree is critical.
Interview process - Interview with Blossom and one other team managers. Virtual interview
Responsibilities:
• 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 Baxter 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.
Education/Experience:
• 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
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