Senior Supplier Quality Engineer – Plastics

Stark Pharma Solutions Inc; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. in Irvine, CA seeks a Senior Supplier Quality Engineer Plastics with strong experience in plastic injection molding, tooling, mold qualification, process validation, and supplier quality.

You will support injection molding processes, tooling development, mold design reviews, IQ/OQ/PQ, CAPA, SCAR, and work with suppliers to ensure FDA and ISO 13485 compliance.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 8+ years of experience in Supplier Quality, Plastics, Manufacturing, or a related engineering field.
• Strong experience with plastic injection molding.
• Experience with larger injection-molded plastic components.
• Experience with injection molding tooling and mold design.
• Experience with mold qualification and process validation.
• Knowledge of IQ, OQ, PQ, and production qualification.
• Experience troubleshooting injection molding defects.
• Strong experience with root-cause analysis and corrective actions.
• Experience with SCAR, CAPA, and 8D.
• Experience working with suppliers and managing supplier quality.
• Knowledge of process capability and continuous improvement.
• Knowledge of FDA requirements and ISO 13485 standards.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Develop and qualify plastic injection molding processes.
• Support injection molding tooling and mold development activities.
• Review mold designs, tooling specifications, and DFM requirements.
• Lead mold design reviews with tooling suppliers and engineering teams.
• Qualify new molds and molding processes for production.
• Perform IQ, OQ, PQ, and process validation activities.
• Troubleshoot injection molding defects and identify root causes.
• Lead supplier corrective actions, SCAR, CAPA, and 8D activities.
• Work with suppliers to improve process capability and product quality.
• Support supplier qualification, tooling development, NPI, and sustaining activities.
• Support continuous improvement and process optimization activities.
• Collaborate with Quality, Manufacturing, Engineering, Operations, and suppliers.
• Ensure processes and supplier activities comply with FDA and ISO 13485 requirements.

Skills

Supplier Quality

Plastics

Manufacturing

Injection Molding

Root-Cause Analysis

CAPA & 8D

FDA & ISO 13485

Cross-Functional Collaboration

Education

Bachelor's degree in Engineering

Tools

Mold Design

Injection Molding Tooling

Job description

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India.

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Senior Supplier Quality Engineer Plastics

Location: Irvine, CA

Duration: Long Term

Job Overview

We are seeking a Senior Supplier Quality Engineer Plastics with strong experience in plastic injection molding, tooling, mold qualification, process validation, and supplier quality. The role will focus on supporting injection molding processes, supplier quality activities, tooling development, and process improvement within a regulated medical device environment.

Key Responsibilities

• Develop and qualify plastic injection molding processes.
• Support injection molding tooling and mold development activities.
• Review mold designs, tooling specifications, and DFM requirements.
• Lead mold design reviews with tooling suppliers and engineering teams.
• Qualify new molds and molding processes for production.
• Perform IQ, OQ, PQ, and process validation activities.
• Troubleshoot injection molding defects and identify root causes.
• Lead supplier corrective actions, SCAR, CAPA, and 8D activities.
• Work with suppliers to improve process capability and product quality.
• Support supplier qualification, tooling development, NPI, and sustaining activities.
• Support continuous improvement and process optimization activities.
• Collaborate with Quality, Manufacturing, Engineering, Operations, and suppliers.
• Ensure processes and supplier activities comply with FDA and ISO 13485 requirements.

Required Qualifications

• Bachelor s degree in Engineering or a related technical field.
• 8+ years of experience in Supplier Quality, Plastics, Manufacturing, or a related engineering field.
• Strong experience with plastic injection molding.
• Experience with larger injection-molded plastic components.
• Experience with injection molding tooling and mold design.
• Experience with mold qualification and process validation.
• Knowledge of IQ, OQ, PQ, and production qualification.
• Experience troubleshooting injection molding defects.
• Strong experience with root-cause analysis and corrective actions.
• Experience with SCAR, CAPA, and 8D.
• Experience working with suppliers and managing supplier quality.
• Knowledge of process capability and continuous improvement.
• Knowledge of FDA requirements and ISO 13485 standards.
• Strong communication and cross-functional collaboration skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.