Supplier Quality Engineer

Fusion Life Sciences Technologies is a tech-oriented organization at the intersection of engineering excellence and workforce scalability. We partner with Fortune 500 clients to deliver contingent workforce solutions, project-based engineering services, and digital innovation that accelerate time-to-market, enhance compliance, and reduce cost.

We believe that strong people build strong companies — and our work focuses on connecting skilled talent and technical capability to help clients deliver projects faster, improve operational performance, and maintain compliance in mission-critical environments.

Medical device company focused on women's health is seeking a Senior Supplier Quality Engineer with 5+ years of experience in medical device manufacturing and strong expertise in plastic injection molding and tooling.
Responsibilities
Develop and qualify injection molding processes and production cells.
Lead mold design reviews and work with suppliers on tooling development.
Qualify new molds and molding processes for production, including IQ/OQ/PQ.
Troubleshoot molding defects and lead root-cause/corrective-action activities.
Partner with suppliers on process capability, quality issues, and continuous improvement.
Support supplier qualification, NPI, and sustaining quality activities.
Ensure processes meet applicable FDA and ISO 13485 requirements.
Requirements
5+ years of Supplier Quality, Manufacturing Quality, or Process Engineering experience in medical devices.
Strong hands-on experience with plastic injection molding and mold qualification.
Experience with mold design reviews and injection molding defect troubleshooting.
Knowledge of process validation, IQ/OQ/PQ, CAPA, SCARs, and root-cause analysis.
Ability to work directly with molding suppliers and cross-functional engineering teams.
Bachelor's degree in Engineering or related technical field.

5+ years of Supplier Quality, Manufacturing Quality, or Process Engineering experience in medical devices.
Strong hands-on experience with plastic injection molding and mold qualification.
Experience with mold design reviews and injection molding defect troubleshooting.
Knowledge of process validation, IQ/OQ/PQ, CAPA, SCARs, and root-cause analysis.

All your information will be kept confidential according to EEO guidelines.