Overview
Quality Engineer Jobs in California, United States at United Pharma Technologies Inc
Title: Quality Engineer
Company: United Pharma Technologies Inc
Location: California, United States
Job Title: Quality Engineer (Medical Device)
Location: Onsite – California
Job Summary:
We are seeking an experienced Quality Engineer to support New Product Development (NPD) and sustaining engineering projects for electro-mechanical active implantable medical devices. The ideal candidate will bring a strong background in design transfer, process improvements, and risk management within the regulated medical device industry.
Key Responsibilities:
Provide quality engineering support for New Product Development and sustaining engineering activities.
Lead and support design transfer and design change processes.
Identify and implement process improvements to enhance product quality and manufacturing efficiency.
Manage and resolve deviations, non-conformances, and quality-related issues.
Perform risk assessments and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory, and Quality Assurance.
Required Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Minimum 3–5 years of quality engineering experience in the medical device industry.
Direct experience with active implantable or medical electromechanical devices is mandatory.
Proven expertise in risk management, design controls, and CAPA.
Strong knowledge of regulatory and quality standards (ISO 13485, FDA QSR).
