Supplier Quality Engineer

Job Title: Supplier Quality Engineer Location: North Haven, CT Type: 12+ Month Contract

Experience: 5 - 8 Years Citizenship Requirement: US Citizen, Green Card Holder, or TN Visa only (No OPT, CPT, or other visa types)

Job Summary:

We’re seeking a Supplier Quality Engineer to support Contract Manufacturers (CMs) involved in Robotics Surgical Technologies. This role is central to managing and improving quality systems for finished goods suppliers, ensuring compliance with internal standards and regulatory requirements (ISO13485, GMP, FDA CFR 820). You’ll work closely with suppliers, internal teams, and new product development to drive quality performance, process improvements, and compliance.

Key Responsibilities:

Own supplier quality activities for finished goods Contract Manufacturers (CMs)

Lead supplier selection, qualification, and performance improvement initiatives

Manage and process Supplier Change Requests (SCRs), ensuring proper approval and documentation

Develop and maintain Quality Plans, Control Plans, PFMEA, SPC, MSAs, and related documentation

Conduct and support Process Validation, PPAP qualifications, and component changes

Develop and execute supplier audit plans; ensure supplier compliance with ISO 13485, GMP, and 21 CFR Part 820

Collaborate with CMs to build robust SCAPAs and CAPAs

Actively support supplier development initiatives such as certification, performance metrics, lean/six sigma integration

Work with cross-functional teams including R&D, Quality, and Manufacturing during New Product Development (NPD)

Handle customer complaints related to CM products, driving root cause analysis and corrective action

Represent the Supplier Quality function in strategic initiatives across global teams

Set and track KPIs related to supplier quality and compliance

Foster strong partnerships with CMs to align on shared goals and performance expectations

Required Qualifications:

Bachelor’s Degree in Engineering or related field

Minimum 5 + years of experience in the Medical Device industry

Proven experience with PPAP, CAPA, TMV, PFMEA, Control Plans, Supplier Evaluations

Solid understanding of ISO13485 and GMP compliance requirements

Experience with process improvements, change control, and qualifying component changes

Strong collaboration and communication skills across technical and non-technical stakeholders

Preferred Qualifications

• Experience in robotics or surgical technologies

• Familiarity with Lean, Six Sigma, and supplier development frameworks

• Prior experience with Contract Manufacturing organizations (CMOs)