Supplier Quality Engineer

I3 INFOTEK INC; Illinois; Hybrid; Full time

Job summary

An established industry player in medical devices is seeking a Supplier Quality Engineer to drive supplier quality activities for a high-impact integration project. This role offers the chance to work with a leading company, ensuring compliance with regulations and improving quality processes. You'll collaborate with cross-functional teams and gain hands-on experience in supplier quality management and regulatory affairs. This position combines the flexibility of a hybrid work model with the opportunity to contribute to significant projects in the medical device sector. If you're passionate about quality and compliance, this role is perfect for you.

Benefits

Flexible work model

Collaborative team environment

Hands-on experience in quality management

Qualifications

• 1+ years of experience in Supplier Quality or Quality Engineering in medical devices.
• Strong knowledge of FDA regulations and quality management systems.

Responsibilities

• Manage supplier quality processes for rebranding and labeling compliance.
• Conduct risk assessments and support supplier audits.

Skills

Supplier Quality Management

Risk Assessment

Analytical Skills

Communication Skills

Documentation Skills

Education

Bachelor’s degree in Engineering

Tools

TrackWise

Veeva Vault

MasterControl

Job description

Direct message the job poster from I3 INFOTEK INC

Associate Manager || US Operations || MSP/VMS || RPO || Hiring Top Talent & Market Research || IT, Non-IT and Life Science Industries || Contact me…

Role: Supplier Quality Engineer

Location: MN (Hybrid – Remote & Onsite) ( in two Locations)

Duration: 6+ Months (Potential Extension)

Rate :$35/hr W2

1+ years of US experience in Supplier Quality, Manufacturing Quality, or Quality Engineering in the medical device industry.

Job Overview:

Our client, a leading medical device manufacturer, is seeking a Supplier Quality Engineer (SQE) to support an ongoing integration project following a recent acquisition. The primary focus of this role will be managing supplier quality activities related to the labeling, rebranding, and compliance verification of 425 SKUs transferred from the acquired company.

This role requires an individual with expertise in medical device regulations (FDA, ISO 13485, EU MDR), supplier quality management, risk assessment, and validation processes. The engineer will work closely with cross-functional teams, suppliers, and regulatory teams to ensure that labeling changes meet regulatory, quality, and safety standards.

Key Responsibilities:

• Supplier Quality & Integration Support: Manage supplier quality processes related to the rebranding and labeling of newly acquired products in compliance with medical device industry regulations.
• Labeling & Regulatory Compliance: Verify and validate input/output labeling changes, ensuring all modifications (including name changes, branding updates, and format revisions) comply with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.
• Change Control & Documentation: Work within the quality management system (QMS) to review and approve engineering change orders (ECOs), supplier change notifications (SCNs), and labeling updates.
• Risk Management: Conduct risk assessments (FMEA) and supplier evaluations to ensure continued compliance with quality standards.
• Process Improvement & Quality Assurance: Collaborate with cross-functional teams (Regulatory Affairs, R&D, Manufacturing, and Supply Chain) to improve supplier processes and ensure seamless integration of new products.
• Audits & Supplier Compliance: Support supplier audits and corrective and preventive action (CAPA) investigations, ensuring alignment with GMP and ISO 14971 risk management principles.
• Technical Support & Troubleshooting: Assist in resolving quality issues, non-conformances, and supplier deviations, working closely with the Supplier Quality Manager and Senior Engineer.

Required Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial) or a related technical field.
• 3+ years of experience in Supplier Quality, Manufacturing Quality, or Quality Engineering in the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and GMP regulations.
• Experience with labeling compliance, change control, supplier management, and validation processes.
• Proficiency in quality tools such as FMEA, CAPA, Root Cause Analysis (RCA), and Risk Assessment.
• Experience working in a QMS environment (TrackWise, Veeva Vault, MasterControl, or similar).
• Strong analytical, communication, and documentation skills to collaborate with internal teams, suppliers, and regulatory bodies.

Preferred Qualifications:

• Experience with ECOs, SCNs, and Change Management in a regulated medical device environment.
• Knowledge of UDI (Unique Device Identification) and GS1 labeling requirements.
• Experience conducting supplier audits and risk assessments.
• Six Sigma or Lean Manufacturing certification (preferred but not required).

Why Join?

• Opportunity to work with a leading medical device company on a high-impact integration project.
• Hybrid work model with flexibility.
• Gain hands-on experience in supplier quality management, labeling compliance, and regulatory affairs.
• Work with a collaborative team of industry professionals, including Supplier Quality Managers and Senior Engineers.

Seniority level

• Entry level

Employment type

• Contract

Job function

• Industries
• Medical Equipment Manufacturing