Supplier Quality Engineer

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.