Quality Supplier Specialist

Baxter Healthcare - Welch Allyn de Mexico, S. de R.L. de C.V.; Tijuana; Presencial; MXN 30,000 - 45,000; Jornada completa

Descripción de la vacante

A leading healthcare company is seeking a Supplier Quality Engineer to oversee supplier quality monitoring and improvement in Tijuana. The role involves conducting supplier audits, ensuring compliance with FDA and ISO standards, and collaborating with sourcing staff to resolve quality issues. Ideal candidates will have a B.S. in Engineering and extensive experience in supplier audits, with strong problem-solving and communication skills.

Formación

• 5+ years of relevant experience, including supplier audits.
• Knowledge of FDA CFR 820, ISO 13485, and ISO 9000 requirements.
• ISO 13485 Lead Auditor certification strongly desired.

Responsabilidades

• Plan and coordinate supplier audits domestically and internationally.
• Follow up on supplier audits for compliance with standards.
• Develop inspection and testing techniques for parts.

Conocimientos

Documentation

Communication

Problem-Solving

Educación

B.S. Degree in Engineering

Descripción del empleo

Your Role at Baxter

This position involves supplier quality monitoring and improvement, focusing on resolving quality issues related to supplied parts. The role includes coordinating problem-solving efforts for supplied parts.

What you'll be doing

1. Plan, coordinate, schedule, and complete supplier audits domestically and internationally as needed.
2. Follow up on supplier audits to ensure compliance with FDA CFR 820, ISO 13485, and ISO 9000 standards.
3. Collaborate with sourcing staff to coordinate supplier audit activities.
4. Develop inspection and testing techniques to evaluate parts and work with suppliers to resolve issues.
5. Create written reports and communicate results clearly to auditees and management.
6. Manage and ensure timely implementation of supplier corrective action reports (SCARs).
7. Provide engineering support for non-conforming material (NMR) issues and authorizations.
8. Remediate supplier files to support current operations and business development, including acquisitions.
9. Verify that supplier files are properly maintained and documented.
10. Lead the supplier approval process by assessing manufacturing and quality system capabilities, risks, and developing improvement plans for critical suppliers.
11. Manage personnel to reduce the incoming inspection cycle time.
12. Establish problem-solving strategies and collaborate with manufacturing and quality engineers to reduce MRB inventory.
13. Perform component characteristic analysis to determine inspection status changes.

What you'll need

• B.S. Degree in Engineering and 5+ years of relevant experience, including supplier audits.
• Excellent documentation, communication, and problem-solving skills.
• Knowledge of FDA CFR 820, ISO 13485, and ISO 9000 requirements; ISO 13485 Lead Auditor certification is strongly desired.
• Experience working with a high volume of suppliers and managing at least 4,000 components.
• Advanced level of English proficiency.