Supplier Quality Engineer II

Job Title: Supplier Quality Engineer II



Location: North Haven, CT Onsite



Duration: 1 year



Rate: $70/hr on W2

Job Summary

We are seeking a Supplier Quality Engineer II to support Contract Manufacturers (CMs) and suppliers within a medical device and surgical robotics environment. This role will focus on supplier quality, QMS activities, supplier qualification, change management, validation, and continuous improvement.

Key Responsibilities

• Manage supplier quality activities for new and existing Contract Manufacturers.

• Lead/review SCRs, Validation, TMV, PPAP, SCAPA, and QMS activities.

• Develop and maintain Quality Plans, Control Plans, FMEAs/PFMEAs, and MSAs .

• Support supplier qualification, audits, performance monitoring, and corrective actions.

• Resolve supplier quality issues and drive process and quality improvements.

• Ensure compliance with ISO 13485, 21 CFR Part 820, and GMP requirements.

• Collaborate with Engineering, Quality, Operations, and suppliers.

Required Qualifications

• Bachelor's degree in Engineering, Scientific, Electronic, or related technical field.

• 4+ years of relevant experience , or an advanced degree with 2+ years of experience.

• Experience in Supplier Quality or Quality Engineering , preferably in the medical device industry.

• Strong knowledge of ISO 13485, 21 CFR 820, QMS, PPAP, FMEA, and validation .

• Strong analytical, communication, and problem-solving skills.