Specialist Supplier Quality, Baxter

Baxter

Location:
Mexico, Tijuana

Category:
Quality Control

Contract Type:
Employment contract

Salary:

Not provided

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Job offer has expired

Job Description:

This position participates in supplier quality related supplier performance monitoring and improvement. It coordinates the resolution of quality problems of supplied parts. This role is essential in monitoring and improving supplier performance, addressing quality issues, managing supplier corrective actions, and leading the supplier approval process while ensuring compliance with FDA CFR 820, ISO 13485, and ISO 9000.

Job Responsibility:

Plan, coordinate, schedule, complete supplier audits domestically and internationally as the need arises
Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000
Work with sourcing staff to coordinate supplier audit activities as need it
Develops inspection, test and test techniques to evaluate parts and works with suppliers to find solutions to identified problems
Create written reports and communicate the results clearly and effectively to auditee and Hillrom management
Manage and insure timely implementation of supplier corrective action reports (SCARs)
Provide engineering support for non-conforming material (NMR) issues and authorization
Remediate Supplier files to support current and business development activity related to acquisition of new businesses
Verify supplier files are maintained and documented appropriately
Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks and 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

Requirements:

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
Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification
Advance level of English

What we offer:

Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Specialist Supplier Quality