MedTech Supplier Quality Engineer — Injection Molding & Molds

Intellectt INC; California (MO); On-site; USD 59,000 - 69,000; Part time

Job summary

Intellectt INC. is seeking a Supplier Quality Engineer with 5+ years in the medical device sector, focused on plastic injection molding, tooling, and mold qualification. This onsite California role demands hands-on quality engineering to bolster supplier processes and NPI efforts.

Responsibilities include leading mold design reviews, mold qualification (IQ/OQ/PQ), CAPA, and root-cause analysis while ensuring FDA and ISO 13485 compliance across supplier activities.

Qualifications

• 5+ years of supplier/manufacturing quality or process engineering in medical devices.
• Hands-on experience with plastic injection molding, tooling, and mold qualification.
• Experience with mold design reviews, molding process development, and defect troubleshooting.
• Strong knowledge of IQ/OQ/PQ, process validation, CAPA, SCAR, root cause analysis, and process capability.
• Experience collaborating with molding suppliers and cross-functional teams.
• Familiarity with FDA regulations and ISO 13485 requirements.

Responsibilities

• Develop, optimize, and qualify plastic injection molding processes, molds, and production cells.
• Lead mold design reviews, tooling development, and new mold qualification (IQ/OQ/PQ).
• Troubleshoot molding defects and drive root cause analysis, CAPA, and corrective actions.
• Collaborate with molding suppliers on process capability and supplier quality issues.
• Support supplier qualification, NPI, process validation, and sustaining quality activities.
• Ensure molding processes and supplier activities comply with FDA and ISO 13485 requirements.

Skills

Supplier quality

Mold injection molding

CAPA & RCA

Process validation

FDA & ISO 13485

Education

Bachelor's degree in Engineering

Tools

Mold design reviews

IQ/OQ/PQ

Job description

Intellectt INC. is seeking a Supplier Quality Engineer with 5+ years in the medical device sector, focused on plastic injection molding, tooling, and mold qualification. This onsite California role demands hands-on quality engineering to bolster supplier processes and NPI efforts.

Responsibilities include leading mold design reviews, mold qualification (IQ/OQ/PQ), CAPA, and root-cause analysis while ensuring FDA and ISO 13485 compliance across supplier activities.