Plastic Injection Molding Quality Engineer Jobs in California

* Supplier Quality Engineer (Plastics)*
**Location:** San Diego, CA – Onsite
**Contract:** 6 - 12 Months
**Experience:** 8+ Years
**Industry:** Medical Devices
**Degree:** Bachelor's Degree in Engineering or related technical field
## Position Overview
A leading medical device company focused on **women's health** is seeking a **Senior Supplier Quality Engineer (Plastics)** with strong hands-on expertise in **plastic injection molding, tooling, mold qualification, and supplier quality engineering**.
This role requires **real injection molding and tooling experience with larger plastic components**. Candidates whose experience is limited to **plastic parts, catheters, tubing, or similar small medical device components will not be considered**.
The ideal candidate will be comfortable working directly with molding suppliers, reviewing mold designs, developing and qualifying molding processes, troubleshooting molding defects, and supporting production readiness.
## Key Responsibilities
* Develop and qualify **plastic injection molding processes and production cells**.
* Lead and participate in **mold design reviews** with tooling suppliers and engineering teams.
* Review tooling designs, mold specifications, DFM considerations, and manufacturing requirements.
* Qualify new molds and injection molding processes for production.
* Execute and support **IQ/OQ/PQ process validation** activities.
* Troubleshoot injection molding defects and lead root-cause investigations.
* Develop and implement corrective and preventive actions for molding-related quality issues.
* Partner with suppliers on process capability, quality improvements, and continuous improvement initiatives.
* Support supplier qualification, NPI, tooling development, and sustaining engineering activities.
* Lead or support **SCAR, CAPA, 8D, root-cause analysis, and corrective action** activities.
* Evaluate process capability and ensure molding processes are robust and production-ready.
* Collaborate with Design Engineering, Manufacturing Engineering, Quality, Operations, and external suppliers.
* Ensure manufacturing processes comply with applicable **FDA and ISO 13485** requirements.
## Required Qualifications
* **7+ years** of experience in Supplier Quality, Manufacturing Quality, Process Engineering, or a similar role within the **medical device industry**.
* Strong, hands-on experience with **plastic injection molding and tooling**.
* Experience with **larger injection-molded plastic components**.
* Experience developing and qualifying injection molding processes and production cells.
* Strong experience with **mold qualification and process validation**.
* Experience conducting **mold design reviews**.
* Demonstrated ability to troubleshoot injection molding defects and determine root cause.
* Experience with **IQ/OQ/PQ**, process capability, and production qualification.
* Knowledge of **CAPA, SCAR, 8D, root-cause analysis, and supplier quality processes**.
* Experience working directly with injection molding and tooling suppliers.
* Strong communication and cross-functional collaboration skills.
* Bachelor's degree in Engineering or related technical discipline.
## Must-Have Injection Molding Experience
**Candidates must be able to demonstrate practical experience with:**
* Plastic injection molding
* Injection molding tooling and mold design
* Larger molded plastic components
* Mold design reviews
* Mold qualification
* Injection molding process development
* Process validation / IQ/OQ/PQ
* Molding defect troubleshooting
* Root-cause analysis and corrective action
* Supplier management and process capability
**Not acceptable as primary experience:**
Candidates whose background is limited to catheters, tubing, or similar small plastic medical device components without significant injection molding/tooling expertise.
4. **In your opinion, what is the hardest injection molding defect to address, and why?**
5. **Walk us through your process for qualifying a mold for production, including IQ/OQ/PQ.**
## Ideal Candidate
The ideal candidate is a **hands-on plastics/SQE professional** who understands injection molding beyond simply inspecting finished plastic parts. They should be able to independently work with tooling suppliers, review mold designs, develop molding processes, troubleshoot defects, qualify molds, and drive supplier corrective actions.
**If you have strong injection molding and tooling expertise with larger molded components and can confidently answer the five technical questions above, we would like to hear from you.**