Supplier Qual Engineer II - Exempt

We are seeking a dedicated Supplier Quality Engineer to join our team in North Haven, CT. This role is crucial for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. The position is urgent, and the hiring manager is ready to take action on candidates right away.

Responsibilities

• Manage all Quality Management System (QMS) related matters pertaining to supplier selection, processing supplier change requests, part/process qualification, manufacturing, QMS development, and technical quality/service/cost improvements.
• Collaborate with new and existing Client/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, PPAP, SCR, Quality Plans, Control Plans, and FMEAs.
• Ensure suppliers deliver quality parts, materials, and services by qualifying them according to company standards and administering a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited regularly to meet good manufacturing practices (GMP) and quality standards.
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in the assessment of their operation.

Top Technical Skills Required

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

Education and Experience

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

Work Schedule and Location

This is a full-time position requiring 40 hours per week, located onsite at 60 Middletown Ave, North Haven, CT 06473.

Why North Haven, CT?

North Haven offers a vibrant community with a rich history, excellent schools, and a convenient location. It's a great place to work and live, providing a perfect balance between professional growth and quality of life.