Job Description

Job Summary:

The Supplier Quality Engineer will be responsible for activities to promote supplier quality, conducting audits, and implementing quality improvement initiatives to ensure the delivery of high-quality materials from suppliers. This role will involve collaborating with internal teams and suppliers to drive continuous improvement in quality and reliability.

Job Duties and Responsibilities:

1. Conduct supplier audits to evaluate quality systems, processes, and compliance with quality standards.
2. Develop and implement supplier quality programs to assess and improve supplier performance.
3. Routine maintenance of approved supplier list in accordance with applicable quality standards.
4. Collaborate with suppliers in a timely manner to resolve quality/delivery issues, implement corrective actions, and prevent reoccurrence.
5. Execute supplier change notices (SCN).
6. Monitor and analyze supplier quality performance metrics to drive improvement and ensure compliance with quality requirements.
7. Work closely with cross-functional teams, including engineering, manufacturing, and procurement, to address quality-related issues and ensure product quality.
8. Implement quality control measures and inspection procedures to validate incoming materials and components.
9. Provide guidance and support to suppliers on quality requirements, specifications, and quality management systems.
10. Work in a cross-functional, collaborative, team-based environment
11. Travel approximately 10%

Qualifications and Requirements:

· Bachelor’s degree or 3-5 years equivalent experience
· Demonstrated experience in areas, which may include, process qualification and validation for medical device, materials qualification and validation, problem solving and root cause analysis methods, and risk management methods.
· Proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel.
· Experience in use of statistical analysis software.
· Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.

Preferred Qualifications:

Experience in processes, equipment, and control methodologies for the following commodity industries:
• Printed Circuit Board Assemblies (PCBA) and Printed Circuit Boards
• Stamping and Machining
• Injection Molding
• Displays and Overlays
ERP/MRP systems experience preferred.
Lead Quality Auditor training/certification (ISO 13485 and/or FDA QSR)
· Experience in partnering with Sourcing and Materials professionals
· Demonstrated leadership behaviors including effective communication at various functional levels, critical thinking and decision making, change agent, and embodying a strong sense of urgency.

Working Conditions and Requirements:

• Must be authorized to work in the United States