Supplier Quality Engineer II — Medical Device Quality

Responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies

• Lead, support, review and approve supplier change request (SCR), PPAP, Validation, TMV, MSA, SCAR/SCAPA, QMS, etc.
• 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.
• Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards etc.

• Bachelor’s Degree in Engineering/Scientific/Electronic or technical field.
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

• 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.