Quality Engineer, New Jersey

Responsibilities:

Our client is searching for a Quality Engineer to support various activities for their specimen management instruments.

This role is critical in ensuring the ongoing quality and compliance of supplier-provided components and materials.

The ideal candidate will work cross-functionally with internal teams and external suppliers to address quality issues, support design control and change management, and maintain a robust supplier quality system in alignment with regulatory requirements.

Serve as the primary quality liaison for sustaining engineering efforts related to change control and design control.

Monitor and improve supplier performance through metrics, audits, and continuous improvement activities.

Collaborate with R&D, Manufacturing, Regulatory, and various quality teams to support design changes, material changes, and process improvements.

Maintain documentation and records in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 1497

Support supplier quality risk management activities, including risk assessments and periodic reviews.

Assist with Process Validation efforts as well as give insight into the Assurance efforts on the operations team

Requirements:

5-7 years of experience in quality engineering, within the medical device industry.

Strong analytical, problem-solving, and communication skills.

Experience working directly with suppliers, including audit, quality agreements, and performance management.

Familiarity with quality tools (e.g., 8D, FMEA, root cause analysis, CAPA).

Strong cross functional communication skills.

Strong understanding of design control and change control.