Supplier Quality Engineer

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