Supplier Quality Engineer II

Supplier Quality Engineer II (12-month contract // North Haven, CT):

Top 3 Skills:

1. Lead, support, review and approve supplier change request (SCR), PPAP, Validation, TMV, MSA, SCAR/SCAPA, QMS, etc.
2. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities including Quality Plans, Control Plans, and FMEAs.
3. Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

Education Required: Bachelor’s Degree in Engineering/Scientific/Electronic or technical field.

Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Description:

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, part/process qualification, manufacturing, QMS development, and technical quality/service/costs improvements. Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs.

Duties:

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.